Sr. Regulatory Ad Promo Manager

Neurocrine Biosciences • San Diego, CA

4d • $158,100 - $216,000

About The Position

Responsible for leading the regulatory review of medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads the Promotional Review Committee (PRC) process for assigned products and independently reviews materials as a subject matter expert to ensure compliance with FDA regulations, guidance, and internal policies. Works closely with cross-functional teams to support compliant and effective promotional strategies, assess regulatory risk, and ensure timely submissions to FDA.

Requirements

• BS/BA degree in Life/Health Sciences or related field AND 8+ year's of Regulatory Affairs experience at a biotech, pharmaceutical or device company, including significant experience in Advertising & Promotion process management. OR Master’s degree in Life/Health Science or related field AND 6+ years of similar experience noted above
• Anticipates business and industry issues; recommends relevant process / technical / service improvements
• Demonstrates broad expertise or unique regulatory knowledge about advertising and promotion
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities; typically leads lower levels and/or teams
• Excellent computer skills
• Excellent communication, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on the organization
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management and strong project leadership skills
• Exhibits strong organizational skills and high attention to detail.
• Possesses excellent interpersonal skills and can work effectively with a variety of personnel from different functional disciplines
• Ability to work independently with minimal direction, including functional representation within teams and committees to attain group goals
• Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations
• Strong knowledge of electronic document management systems (e.g. Veeva Vault or similar)
• Proficiency in Microsoft Office programs and Adobe Professional

Responsibilities

• Leads the PRC process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for promotional, disease state, and medical education materials
• Represents Regulatory Affairs on the Medical Review Committee (MRC) and conducts regulatory review of materials intended for use by field medical teams
• Independently reviews advertising and promotional materials and provides clear, risk-based regulatory guidance by integrating scientific, regulatory, and business considerations
• Responsible for timely and accurate review and submission of promotional materials, including FDA Form 2253 submissions
• Evaluates FDA guidance, policies, enforcement trends, and the overall regulatory environment to assess and communicate potential regulatory risk and impact
• Fosters strong cross-functional partnerships between Regulatory Affairs and PRC partner functions to support compliant and effective promotional review and approval processes
• Ensures communications and promotional claims comply with approved product labeling, applicable laws, internal policies, and external regulations
• Navigates complex cross-functional discussions and operates independently while appropriately seeking strategic alignment on highly complex, novel, or high-risk issues
• Continually assesses advertising and promotion-related processes and procedures to enhance efficiency, consistency, and compliance and recommends or implements improvements as appropriate
• Maintains standard operating procedures and department working practices
• May mentor and develop more junior team members
• Other duties as assigned

Benefits

• annual bonus with a target of 30% of the earned base salary
• eligibility to participate in our equity based long term incentive program
• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior