Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Manager, Regulatory Affairs US Advertising & Promotion combines knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Has responsibility for 1-2 of the following: therapeutic area, products, or multiple driver indications for a product. Develops and supervises regulatory professionals as needed. Has department/group/site level influence and is generally recognized as an expert and resource within the department. Supports the Director in efforts to influence the regulatory environment. Shares knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.
Responsibilities:
- Effectively presents pertinent information to appropriate cross-functional groups.
- Functions independently in negotiation and decision-making for project related issues that have cross-functional impact. Provides inter-departmental direction and negotiation of regulatory issues. Independently recommends and implements changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidance’s, promotional guidelines, corporate policies, and management related considerations.
- Responsible for high impact and visible departmental project(s). Provides leadership in problem solving with teams.
- Functions as the expert within the job function and the product/disease state. Rapidly understands, evaluates, and identifies issues/problems.
- Develops and executes departmental and therapeutic area strategies.
- Mentors staff, contractors, interns and/or rotational students
- Employs rigorous logic and methods to solve difficult problems independently, effectively, and creatively. Probes multiple sources for answers. Identifies hidden problems and issues beyond the obvious
- Develops solutions for more complex issues with little guidance from management.
- Proactively addresses and resolves issues having potential impact on working relationships and productivity.
- Uses problem solving skills to separate and combine tasks into efficient workflow, makes good decisions based upon a mixture of analysis, experience, and judgment.
This role can be based remotely within the US. If you are located close to an AbbVie site, a hybrid schedule may be requested.
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 degree) preferred
- 6 years pharmaceutical experience in Regulatory Affairs or relevant area
- Experience working in a complex and matrix environment.
- Exhibits strong negotiation skills.
- Strong communication skills, both oral and written
- 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
