BioSpace, Inc.
Executive Director, Labeling, Advertising and Promotion - Regulatory Affairs
BioSpace, Inc., Cambridge, Massachusetts, us, 02140
Job Details
The Role:
The Head of Regulatory Labeling and Advertising and Promotion will lead Modernas labeling and advertising/promotion functions globally, establishing robust, compliant processes to support an expanding product portfolio across therapeutic areas. This role is responsible for regulatory strategy, submission, and compliance in both labeling and AdPromo, ensuring consistency across products and seamless integration across the product lifecycle. As the team leader, this role will provide direction for the development, revision, and submission of labeling and promotional materials to regulatory bodies, including the FDA, and oversee global AdPromo practices to ensure adherence to international standards.
Heres What Youll Do:Leadership & StrategyDefine and execute the vision and mission for the Global Labeling and AdPromo functions in alignment with Modernas regulatory and commercial goals.Lead a cross-functional team to develop and implement end-to-end labeling and AdPromo processes that align with regulatory requirements and optimize operational efficiency.Oversee the creation, update, and submission of the Company Core Data Sheet (CCDS), prescribing information, and labeling artwork.Establish consistent labeling strategies and oversee the development of Target Label Profiles that support clinical development phases (Phases 1-4) and product launch readiness.Act as the subject matter expert on US and global labeling requirements, ensuring products comply with Health Agency guidelines, including the FDA, EMA, and other relevant authorities.Guide promotional strategy, ensuring compliance with FDA regulations, CFR, PhRMA Principles, and international standards for advertising and promotional materials.Labeling ResponsibilitiesLead the end-to-end labeling process for all products, including development, submission, and maintenance of labeling for global markets.Serve as Chair of the Global Labeling Team (GLT), ensuring collaboration with cross-functional partners to develop and approve the CCDS and updated labeling content.Oversee regulatory submission of labeling materials and updates, ensuring compliance with regional requirements and maintaining consistency across products.Provide guidance on clinical trial design to enable desired product claims and oversee regulatory labeling reviews for submissions across different regions.Advertising and Promotion (AdPromo) ResponsibilitiesDirect the regulatory review of promotional and external communications, including media and scientific information, ensuring materials meet FDA and international regulatory requirements.Lead complex submission coordination with APLB, collaborating with cross-functional teams to ensure compliant and timely promotional activities.Partner with cross-functional teams to develop and execute new promotional initiatives, including speaker events, market research, and product sampling.Oversee the preparation and submission of press releases and promotional materials for regulatory review, maintaining awareness of evolving FDA and international promotional regulations.Management & Stakeholder EngagementProvide strategic leadership and development for the Labeling and AdPromo teams, fostering growth and accountability within the function.Collaborate closely with Regulatory Affairs, Commercial, Legal, and Medical Affairs teams to align promotional activities with regulatory compliance and business goals.Maintain engagement with regulatory authorities and industry stakeholders to keep abreast of emerging trends, regulatory updates, and industry best practices.Represent the labeling and AdPromo functions in discussions with senior management, external departments, and global regulatory agencies.Participate in forecasting and planning activities for resources for the Regulatory Affairs group for the future needs for GRS.Heres What Youll Bring to the Table:
Bachelors degree required; advanced degree (e.g., MS, PhD, PharmD) preferred.15+ years of experience in the pharmaceutical/biotech industry with at least 8 years in Regulatory Affairs, with specialized experience in labeling and advertising/promotion.Proven leadership experience managing regulatory teams, including end-to-end labeling and AdPromo functions.Solid project management skills, and deep understanding of Digital ecosystem including AI/ML.Extended knowledge of science and data of assigned products and how that translates into labeling language.Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.Experience of product launch preferred.Demonstrated expertise in technology systems utilized for electronic documentation, including, but not limited to Microsoft Office, Adobe Acrobat, and Veeva.Ad/Promo experience in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.Integrity: overriding commitment to integrity and high standards in self and others.Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.Strategic orientation: ability to link visions and daily workCommunication: ability and intend to effectively explain, describe or convey information to a variety of audiences.Collaborate effectively as member of the Regulatory sub-team and collaborate with business partners, including affiliates and third parties.Develops others: involved in a genuine intent to foster development of others; mentoringFlexibility/adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups.Work collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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The Role:
The Head of Regulatory Labeling and Advertising and Promotion will lead Modernas labeling and advertising/promotion functions globally, establishing robust, compliant processes to support an expanding product portfolio across therapeutic areas. This role is responsible for regulatory strategy, submission, and compliance in both labeling and AdPromo, ensuring consistency across products and seamless integration across the product lifecycle. As the team leader, this role will provide direction for the development, revision, and submission of labeling and promotional materials to regulatory bodies, including the FDA, and oversee global AdPromo practices to ensure adherence to international standards.
Heres What Youll Do:Leadership & StrategyDefine and execute the vision and mission for the Global Labeling and AdPromo functions in alignment with Modernas regulatory and commercial goals.Lead a cross-functional team to develop and implement end-to-end labeling and AdPromo processes that align with regulatory requirements and optimize operational efficiency.Oversee the creation, update, and submission of the Company Core Data Sheet (CCDS), prescribing information, and labeling artwork.Establish consistent labeling strategies and oversee the development of Target Label Profiles that support clinical development phases (Phases 1-4) and product launch readiness.Act as the subject matter expert on US and global labeling requirements, ensuring products comply with Health Agency guidelines, including the FDA, EMA, and other relevant authorities.Guide promotional strategy, ensuring compliance with FDA regulations, CFR, PhRMA Principles, and international standards for advertising and promotional materials.Labeling ResponsibilitiesLead the end-to-end labeling process for all products, including development, submission, and maintenance of labeling for global markets.Serve as Chair of the Global Labeling Team (GLT), ensuring collaboration with cross-functional partners to develop and approve the CCDS and updated labeling content.Oversee regulatory submission of labeling materials and updates, ensuring compliance with regional requirements and maintaining consistency across products.Provide guidance on clinical trial design to enable desired product claims and oversee regulatory labeling reviews for submissions across different regions.Advertising and Promotion (AdPromo) ResponsibilitiesDirect the regulatory review of promotional and external communications, including media and scientific information, ensuring materials meet FDA and international regulatory requirements.Lead complex submission coordination with APLB, collaborating with cross-functional teams to ensure compliant and timely promotional activities.Partner with cross-functional teams to develop and execute new promotional initiatives, including speaker events, market research, and product sampling.Oversee the preparation and submission of press releases and promotional materials for regulatory review, maintaining awareness of evolving FDA and international promotional regulations.Management & Stakeholder EngagementProvide strategic leadership and development for the Labeling and AdPromo teams, fostering growth and accountability within the function.Collaborate closely with Regulatory Affairs, Commercial, Legal, and Medical Affairs teams to align promotional activities with regulatory compliance and business goals.Maintain engagement with regulatory authorities and industry stakeholders to keep abreast of emerging trends, regulatory updates, and industry best practices.Represent the labeling and AdPromo functions in discussions with senior management, external departments, and global regulatory agencies.Participate in forecasting and planning activities for resources for the Regulatory Affairs group for the future needs for GRS.Heres What Youll Bring to the Table:
Bachelors degree required; advanced degree (e.g., MS, PhD, PharmD) preferred.15+ years of experience in the pharmaceutical/biotech industry with at least 8 years in Regulatory Affairs, with specialized experience in labeling and advertising/promotion.Proven leadership experience managing regulatory teams, including end-to-end labeling and AdPromo functions.Solid project management skills, and deep understanding of Digital ecosystem including AI/ML.Extended knowledge of science and data of assigned products and how that translates into labeling language.Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.Experience of product launch preferred.Demonstrated expertise in technology systems utilized for electronic documentation, including, but not limited to Microsoft Office, Adobe Acrobat, and Veeva.Ad/Promo experience in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.Integrity: overriding commitment to integrity and high standards in self and others.Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.Strategic orientation: ability to link visions and daily workCommunication: ability and intend to effectively explain, describe or convey information to a variety of audiences.Collaborate effectively as member of the Regulatory sub-team and collaborate with business partners, including affiliates and third parties.Develops others: involved in a genuine intent to foster development of others; mentoringFlexibility/adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups.Work collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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