Senior Manager, US Regulatory Affairs — Advertising & Promotion

AbbVie Inc.; Chicago (IL); Hybride; USD 140 000 - 180 000; Plein temps

Résumé du poste

AbbVie is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion to lead regulatory activities for advertising and promotion. You will oversee staff, coordinate with Marketing, Medical, Legal, and Sales Training, and ensure compliance with CFR, FDA guidance, and PhRMA principles.

The role requires a science degree with extensive US regulatory experience in ad promo, and it offers a hybrid work model (3 days in office, 2 days remote) from AbbVie HQ locations in IL/NJ/CA.

Qualifications

• Bachelor’s degree in science plus 7 years of industry experience in regulatory affairs or related field.
• PharmD degree preferred with 5 years of regulatory or ad promo experience.
• Experience in a complex matrix environment with strong negotiation and communication skills.

Responsabilités

• Capture and disseminate regulatory policy updates impacting AbbVie’s interests.
• Represent department in trade associations and build working relationships.
• Summarize findings in concise reports for distribution within AbbVie.
• Oversee regulatory staff ensuring ads/promotions comply with CFR, FDA guidance, PhRMA, and FDA Act.
• Develop and implement promotional strategies with regulatory input.
• Apply regulatory knowledge across therapeutic areas.
• Ensure training and compliance with promotional regulations for the team.
• Present information to cross-functional groups and manage stakeholder relationships.
• Support a hybrid work schedule: 3 days in office and 2 days remotely at HQ locations.

Connaissances

Negotiation skills

Strong communication

Management experience

Formation

Bachelor's degree in science

PharmD preferred

Description du poste

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

TheSenior Manager Regulatory Affairs US Advertising and Promotioncombines 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

Additional Information

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.

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.

US & Puerto Rico only - to learn more, visithttps://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