Senior Manager RA US Advertising and Promotion - Allergan Aesthetics
AbbVie
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 (https://www.tiktok.com/@abbvie) .
Job Description
The Senior Manager Regulatory Affairs US Advertising and Promotion, Allergan Aesthetics, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Supports the Director/Associate 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:
+ Lead and manage MLRC (Medical Regulatory Committee) meetings and oversee the MLRC Veeva review process with precision and expertise. Develop and provide guidance for implementation strategies for promotional activities
+ Broadly apply regulatory/technical skills and knowledge of FDA regulations and guidances, and precedents across therapeutic areas.
+ Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations
+ Mentor and educate others on regulatory topics, fostering a culture of learning and development.
+ Effectively presents pertinent information to appropriate cross-functional groups.
+ Collaborate with marketing partners to provide regulatory expertise and guidance to help manage business-related risk and meet commercial needs
+ Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal & Compliance, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
+ Stays well-informed of the latest FDA and industry trends through comprehensive industry and competitive intelligence.
+ 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.
+ Represents department and participates in trade associations (DIA, FDLI, etc.) as needed. Summarizes findings, under supervision, in concise reports for distribution within AbbVie/Allergan Aesthetics.
+ Ability to travel 10-15% as needed.
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 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
+ Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
+ Experience working in a complex and matrix environment
+ Exhibits strong negotiation skills
+ Strong communication skills, both oral and written
+ Strong familiarity with social media functionality to leverage digital platforms effectively
+ Operates as an independent contributor, demonstrating autonomy and initiative
+ 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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
Salary: $121,000 - $230,000
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