Company Summary:
My client, a biopharmaceutical company focusing on fighting rare diseases is looking to add a Regulatory professional to their team - they are open to hiring at the Manager level through Associate Director! This role will be hybrid based in Paramus, New Jersey requiring 2 days per week onsite.
This Regulatory professional (who could be a Manager - Associate Director) will be responsible for:
- Supporting and acting as a primary regulatory advertising and promotion reviewer on Legal, Medical, Regulatory (LMR) teams and Medical Review Committees (MRCs)
- Providing pre-submission package (PSP) support and ensuring regulatory reviews are complete
- Assisting in FDA interactions and maintaining a working relationship with effective communication with respect to advertising and promotion matters
- Providing strategic regulatory advice on advertising and promotion materials in accordance with business goals, FDA regulations, PhRMA guidelines and company policy
- Coordinating preparation, compilation, and submission of promotional materials (Form FDA 2253)
This Regulatory professional (who could be a Manager - Associate Director) should have the following qualifications:
- Bachelor's degree with 5+ years of experience in Regulatory Affairs
- Experience working with the FDA and has knowledge of regulations governing the development of pharmaceuticals
- Experience in regulatory launch of new product and sub part H accelerated approval products
- Experience in regulatory commercialization for rare disease and accelerated approval products is preferred
If you are interested in this position, please apply today and do not hesitate to contact me with any questions!
