Senior Manager, Regulatory Affairs Advertising & Promotion - Oncology (Remote)

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion, combines knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment.

Has department / group / site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory.

Shares knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.

Responsibilities :

Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests.

Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations.

Distributes proposed policies to SMEs. Highlights key points in clear and concise manner.

• Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie
• Oversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies.

Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.

• Develops and guides implementation strategies for promotional activities.
• Broadly applies regulatory / technical knowledge of government regulations and skills across therapeutic areas.
• Ensures departmental training and compliance with established regulations, guidance’s, promotional guidelines, and SOPs related to advertising and promotion regulations for self and direct reports.

Manages direct reports and assist in the development, training and mentoring of staff members

• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organization without damage to relationships.
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.

fostering mutually beneficial interactions and exchange.

Open to remote within the United States. If you are located near an AbbVie office, a hybrid schedule may be required.

Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy) Relevant Master’s degree (Pharmacy, advanced scientific or law) preferred
• 7 years pharmaceutical experience in Regulatory Affairs or related area preferred.
• Experience working in a complex and matrix environment and exhibits strong negotiation skills.
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law :

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.

This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical / dental / vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.

This job is eligible to participate in our long-term incentive programs

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

https : / / www.abbvie.com / join-us / reasonable-accommodations.html