Global Regulatory Affairs Associate Director
Company Summary:
Our client, a leading global pharmaceutical company, is looking to add a regulatory strategy professional to their neuroscience division. Their entire pipeline consists of over 52 medications being manufactured, marketed, and distributed in the United States. This role is based in New Jersey, but for the perfect candidate, my client is willing to make this position fully remote.
The Associate Director will be responsible for:
- Developing and implementing North American regulatory strategy
- Acting as the primary contact with North American Health Authorities and operating companies
- Leading and facilitating regional strategy related activities, including providing input on regulatory strategy implications by participating in product-related teams
- Providing regional input to the Global Regulatory Team
- Determining timing, appropriate NA regional strategy and content for all meetings with Health Authorities
- Critically reviewing submission documents to ensure compliance with regulatory requirements
The Associate Director should have the following qualifications:
- A minimum of a bachelor's degree with 8 years of relevant experience or an advanced degree with 6 years of relevant experience. Relevant experience can include pharmaceutical, medical device, or experience with another health regulated industry
- A minimum of 5 years of experience in regulatory affairs preferred
- An understanding of the drug development process and regulatory submission and approval process is preferred
- An understanding of the drug product lifecycle is preferred
If you are interested in this position, please apply today and do not hesitate to contact me with any questions!
