Manager, Regulatory Affairs US Advertising and Promotion
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. Key Responsibilities Include:
- 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 independently and effectively/creatively solve difficult problems. 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.
- 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 preferred.
- 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