Senior Director, Regulatory Affairs Advertising and Promotion
About the position
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications.
Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.
POSITION OVERVIEW
The Senior Director, Regulatory Affairs Advertising and Promotion will be responsible for providing commercial regulatory strategy and oversight in the development, review, and approval of promotional and medical communications related to Collegium products. The Senior Director participates in and leads the Material Review Committee (MRC) process, in partnership with stakeholders in Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance. This role is responsible for providing strategic input that ensures product and disease communications are compliant and meet business objectives.
Responsibilities
• Provide leadership and direction to cross-functional Material Review Committee (MRC) teams developing, reviewing, and approving product promotion, non-promotional disease state, and related communications.
• Assess materials to ensure compliance with regulatory requirements and approved labeling, provide regulatory interpretations of applicable guidance or precedent, articulate risks as applicable and advise on risk mitigations.
• Monitors and maintains up-to-date knowledge of FDA laws, regulations and guidance relevant to advertising and promotions. Assess and communicate impact of changes to Collegium business and stakeholders.
• Build and maintain strong relationships with internal stakeholders including Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance.
• Serve as primary contact for OPDP and ensure timely and accurate submission of product promotional materials to FDA.
• This role may be responsible for mentoring more junior team members to foster their professional development as it relates to Advertising and Promotional review.
Requirements
• Bachelor’s degree required
• Minimum 10 years of related experience in Regulatory Affairs in the Pharmaceutical or Life Sciences, including direct experience in managing commercial products and reviewing promotional materials
• Expert level of applied knowledge of US laws, regulations, guidance, and industry standards related to advertising and promotional communications of prescription drugs
• Excellent interpersonal skills, ability to lead others, and interact with and negotiate internally/externally
• Proven ability to influence cross-functional teams and work effectively with senior management
• Demonstrated decision-making and complex problem-solving capabilities
• Excellent communication skills (oral and written), project management and presentation skills
Nice-to-haves
• Experience with product labeling (USPI) development, maintenance, and labeling processes a plus.
Apply tot his job
Apply To this Job
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications.
Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.
POSITION OVERVIEW
The Senior Director, Regulatory Affairs Advertising and Promotion will be responsible for providing commercial regulatory strategy and oversight in the development, review, and approval of promotional and medical communications related to Collegium products. The Senior Director participates in and leads the Material Review Committee (MRC) process, in partnership with stakeholders in Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance. This role is responsible for providing strategic input that ensures product and disease communications are compliant and meet business objectives.
Responsibilities
• Provide leadership and direction to cross-functional Material Review Committee (MRC) teams developing, reviewing, and approving product promotion, non-promotional disease state, and related communications.
• Assess materials to ensure compliance with regulatory requirements and approved labeling, provide regulatory interpretations of applicable guidance or precedent, articulate risks as applicable and advise on risk mitigations.
• Monitors and maintains up-to-date knowledge of FDA laws, regulations and guidance relevant to advertising and promotions. Assess and communicate impact of changes to Collegium business and stakeholders.
• Build and maintain strong relationships with internal stakeholders including Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance.
• Serve as primary contact for OPDP and ensure timely and accurate submission of product promotional materials to FDA.
• This role may be responsible for mentoring more junior team members to foster their professional development as it relates to Advertising and Promotional review.
Requirements
• Bachelor’s degree required
• Minimum 10 years of related experience in Regulatory Affairs in the Pharmaceutical or Life Sciences, including direct experience in managing commercial products and reviewing promotional materials
• Expert level of applied knowledge of US laws, regulations, guidance, and industry standards related to advertising and promotional communications of prescription drugs
• Excellent interpersonal skills, ability to lead others, and interact with and negotiate internally/externally
• Proven ability to influence cross-functional teams and work effectively with senior management
• Demonstrated decision-making and complex problem-solving capabilities
• Excellent communication skills (oral and written), project management and presentation skills
Nice-to-haves
• Experience with product labeling (USPI) development, maintenance, and labeling processes a plus.
Apply tot his job
Apply To this Job