Company Summary
One of the top pharmaceutical companies in California is looking to make a very important addition to their Regulatory Affairs Ad/Promo team. With 2 products currently in its commercialization stage and 2 others in late development, now is the time to join! This company is renowned for its ability to train, mentor, and establish a clear line of career progression for its team members. Enjoy a competitive salary, bonuses, and the best place for your career to develop.
Overview
We are looking for a detail oriented and personable Regulatory Affairs Advertising and Promotions Senior Manager who has a working knowledge of both US and Global commercial regulations. This position will require collaborations with cross-functional professionals and execution of promotional campaigns. You will be responsible to contribute to the writing and development of commercial regulatory strategy and represent the organization to health authorities.
Responsibilities
- Develop and execute clinical and non-clinical regulatory strategies
- Represents Regulatory Affairs at team meetings
- Provide strategic leadership for regulatory submissions which include IND/CTA, NDA/BLA/MAA
- Responsible for interactions with FDA and other global health authorities
- Complies and coordinates regulatory documents for submission
- Develop essential timelines for all tasks
- Work cross-functionally with clinical, project management, quality, etc. teams
- Participate as a core member of the Regulatory Affairs team
- Work hands-on in a dynamic fast-paced environment
Experience and Qualifications
- Minimum of 5+ years direct related professional experience with a minimum of 2+ years within Regulatory Affairs Advertising and Promotion
- Experience with electronic document management systems (Veeva Vault, Microsoft, Adobe Professional, etc.)
- Proven track record and experience with advertising and promotions review in alignment with regulations and guidelines
- Significant knowledge and understanding of FDA guidelines
- Ability to work independently and take direction from a mentor
- Interpret Regulatory Affairs documents, submissions, and reports
- Excellent verbal and written communication skills
Education
- Minimum of bachelor's degree or above in a life sciences field from an accredited college or university required.
- An advanced degree preferred
If you are interested, apply now before the position is filled!
