Senior Manager RA US Advertising and Promotion - Hybrid

ABBVIE; Florham Park (NJ); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie in Florham Park, NJ is seeking a Senior Manager for Regulatory Affairs US Advertising and Promotion in Neuroscience. You will oversee regulatory operations, guide strategy, and support senior leadership in shaping compliance across promotional activities.

The role combines scientific, regulatory and business acumen, leading a team and collaborating with Marketing, Legal, Clinical, and Medical Affairs to ensure accurate, compliant communications while driving AbbVie's regulatory excellence.

Qualifications

• Bachelor’s degree in science plus 7 years of relevant industry experience.
• PharmD degree plus 5 years of relevant industry experience (preferred).
• Experience in complex, matrix environments and strong negotiation skills.
• Strong communication skills, both oral and written.
• Experience in US Regulatory Affairs Advertising and Promotion.

Responsibilities

• Capture and disseminate regulatory policy developments affecting AbbVie's advertising and promotion.
• Represent department in trade associations and build relationships.
• Summarize findings in concise reports for AbbVie.
• Oversee regulatory staff for advertising and promotion compliance with CFR, FDA guidance, PhRMA, and FDA Cosmetics Act.
• Develop and guide implementation strategies for promotional activities.
• Provide cross-functional communication with Marketing, Medical, Legal, Sales Training, etc.
• Hybrid work arrangement: 3 days in office, 2 days remote at Florham Park, NJ.

Skills

Negotiation skills

Communication skills

Management experience

Regulatory affairs

Education

Bachelor’s degree in science

PharmD degree

Job description

• Full-time
• Salary Min: 124500
• Therapy Area: Neuroscience
• Salary Max: 236500
• Workday Global Grade: 19
• Compensation: USD 124,500 - USD 236,500 - yearly

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Senior Manager Regulatory Affairs US Advertising and Promotion-Neuroscience combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager 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. This individual share knowledge and expertise with others in support of team activities and 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 a 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
• Oversee 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.
• Development and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organizations 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.
• This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
• Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• PreferredPharmD degree plus 5years ofrelevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• 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

Compensation and Benefits

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

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

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

This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

Equal Opportunity

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.