Senior Manager RA US Advertising and Promotion - Allergan Aesthetics
Senior Manager RA US Advertising and Promotion - Allergan Aesthetics
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Salary Not Disclosed
1 Vacancy
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 crossfunctional groups.
- Collaborate with marketing partners to provide regulatory expertise and guidance to help manage businessrelated 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 wellinformed 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 AbbVies 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 1015% as needed.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications :
- Minimum: Bachelors 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Fulltime
Employment Type
Remote
