Axsome Therapeutics, Inc.
Associate Director/Director, Regulatory Affairs Advertising & Promotion
Axsome Therapeutics, Inc., New York, New York, us, 10261
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
About This Role
Axsome Therapeutics is seeking an Associate Director/Director, Regulatory Affairs Advertising & Promotion to The Associate Director/Director, Regulatory Affairs Advertising & Promotion will help to establish and implement the promotional regulatory strategy for the company and will work with the Executive Director, Regulatory Affairs Advertising and Promotion to ensure professional and efficient interactions between the company and Office of Prescription Drug Promotion (OPDP). This role will report to the Executive Director, Regulatory Affairs Advertising and Promotion
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties
include, but are not limited to, the following:
Independently review advertising and promotional labeling materials and internal communications to ensure both are compliant with relevant laws, regulations, and guidance documents related to the proper use and safety of productsPrepare and sign FDA Form 2253 to accompany promotional labeling advertising submissions to OPDPLead submission of promotional materials for FDA advisory commentAnalyze and interpret new regulations, FDA guidance documents, and policy issues as well as monitor and determine the impact of OPDP and Advertising and Promotion Labeling Branch (APLB) correspondences and enforcement actions.Communicate significant changes in FDA perspective to relevant stakeholders.Support the US Commercial teams, including relevant stakeholders, by participating in strategy discussions, labeling negotiations, and extended team meetings; provides regulatory guidance and perspective on marketing strategies and promotion objectives and tacticsIdentify and assist teams in overcoming barriers and finding solutions in achieving quality and complianceProposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory riskMaintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actionsProvide training on advertising and promotion regulations to key stakeholdersIdentify areas of potential regulatory compliance vulnerability and risk; develop/collaborate on corrective measuresCollaborate with other functions (e.g., Medical Affairs, Commercial) on policy and procedure developmentIndependently communicates timing and strategy for revisions to promotional labeling and advertising based on planned or unplanned changes to product labeling, advisory comments, enforcement, or FDA guidance documentsIndependently develop documents related to use of product labeling in promotion and advertising, including but not limited to, policies, procedures, and safety-related claims (i.e., important safety information, brief summary, major statement)Requirements / Qualifications
BS life sciences degree or equivalent required. Advanced academic qualifications/degree such as Pharm.D. or Ph.D. are an advantage but not essential7+ years in the drug development industry with at least 3 years in Regulatory Affairs Advertising and PromotionAbility to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote rolesExperience and Knowledge
Strong attention to detail and excellent organization skillsProven aptitude for analyzing and interpreting scientific dataDemonstrated ability to negotiate, influence without authority, and problem solve in a cross-functional teamStrong interpersonal skills and communication skills (both written and oral)Comfortable multi-tasking in a fast-paced, small company environment and able to adjust workload based upon changing prioritiesWillingness to travel as needed
Salary and Benefits:
The anticipated salary range for this role is $160,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
About This Role
Axsome Therapeutics is seeking an Associate Director/Director, Regulatory Affairs Advertising & Promotion to The Associate Director/Director, Regulatory Affairs Advertising & Promotion will help to establish and implement the promotional regulatory strategy for the company and will work with the Executive Director, Regulatory Affairs Advertising and Promotion to ensure professional and efficient interactions between the company and Office of Prescription Drug Promotion (OPDP). This role will report to the Executive Director, Regulatory Affairs Advertising and Promotion
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties
include, but are not limited to, the following:
Independently review advertising and promotional labeling materials and internal communications to ensure both are compliant with relevant laws, regulations, and guidance documents related to the proper use and safety of productsPrepare and sign FDA Form 2253 to accompany promotional labeling advertising submissions to OPDPLead submission of promotional materials for FDA advisory commentAnalyze and interpret new regulations, FDA guidance documents, and policy issues as well as monitor and determine the impact of OPDP and Advertising and Promotion Labeling Branch (APLB) correspondences and enforcement actions.Communicate significant changes in FDA perspective to relevant stakeholders.Support the US Commercial teams, including relevant stakeholders, by participating in strategy discussions, labeling negotiations, and extended team meetings; provides regulatory guidance and perspective on marketing strategies and promotion objectives and tacticsIdentify and assist teams in overcoming barriers and finding solutions in achieving quality and complianceProposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory riskMaintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actionsProvide training on advertising and promotion regulations to key stakeholdersIdentify areas of potential regulatory compliance vulnerability and risk; develop/collaborate on corrective measuresCollaborate with other functions (e.g., Medical Affairs, Commercial) on policy and procedure developmentIndependently communicates timing and strategy for revisions to promotional labeling and advertising based on planned or unplanned changes to product labeling, advisory comments, enforcement, or FDA guidance documentsIndependently develop documents related to use of product labeling in promotion and advertising, including but not limited to, policies, procedures, and safety-related claims (i.e., important safety information, brief summary, major statement)Requirements / Qualifications
BS life sciences degree or equivalent required. Advanced academic qualifications/degree such as Pharm.D. or Ph.D. are an advantage but not essential7+ years in the drug development industry with at least 3 years in Regulatory Affairs Advertising and PromotionAbility to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote rolesExperience and Knowledge
Strong attention to detail and excellent organization skillsProven aptitude for analyzing and interpreting scientific dataDemonstrated ability to negotiate, influence without authority, and problem solve in a cross-functional teamStrong interpersonal skills and communication skills (both written and oral)Comfortable multi-tasking in a fast-paced, small company environment and able to adjust workload based upon changing prioritiesWillingness to travel as needed
Salary and Benefits:
The anticipated salary range for this role is $160,000 - $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.