Senior Director Regulatory Affairs
Summary: This company is one of the world's leading global generic pharmaceutical companies. Dedicated to making a difference and changing lives, this company is actively looking to expand their regulatory affairs department. They have a growing portfolio of over 7000 products on the market all with the intent to provide the world with access to high quality medicine.
As Senior Director of Regulatory Affairs, Biologics, an individual will have the opportunity to contribute to the company's growth as a team lead. In this position an individual will double as the regulatory lead for 3 global development biosimilars programs.
The Senior Director, Regulatory Affairs will be responsible for:
- Carrying out regional regulatory strategic and tactical activities in accordance to certain milestones
- Overseeing day to day regulatory work to ensure project deadlines are met
- Maintaining strategic oversight of global projects and be operational/hands on with US development programs and submissions
- Reviewing technical documentations for with legislation and providing feedback in a timely manner
- Managing preparation, submission and review of Market Authorizations while following relevant directives, guidelines and regulations
The Senior Director, Regulatory Affairs should have the following qualifications:
- Bachelor's in science field
- 10+ years Regulatory Affairs Experience
- Knowledge and experience of CTA's, BLA's and IND's
- Ability to supervise employees in accordance to company policies
- Strong technical background with profound communication and organizational skills
- Biologics experience and experience with the Biologics division of FDA (preferred)
