Regulatory Affairs Contractor (Remote, USA)
As a Regulatory Affairs Contractor, you will support the development and implementation of global regulatory CMC strategies for our partners' marketed and development products. You will assist with regulatory activities for both internal and external programs, working closely with cross-functional subject matter experts to ensure effective partnerships, regulatory compliance, and timely submission and approval of global regulatory filings.
Responsibilities:
- Review regulatory submission documents and support regulatory filings
- Interpret regulations and provide well-reasoned regulatory guidance to cross-functional project teams
- Support and lead in the preparation of health authority meeting materials and lead responses to requests for information
- Research, prepare, and present on global regulatory topics to internal and external collaborators
- Ensure compliance with all applicable regulations, including regulatory change management
Requirements:
- A minimum of a BS degree in science with at least 3 years of experience in Regulatory Affairs CMC in the biotech/pharmaceutical industry (an equivalent combination of education and experience will be considered)
- Proven experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations
- Proven experience and success in applying regulatory knowledge to various situations
- Excellent writing, communication, and interpretive skills
- Experience with European/global submissions is a plus
- Experience in regulatory management of commercial products is a plus.
