A pharmaceutical company with a diverse portfolio of products and a wealth of opportunity for growth is looking to hire for a Manager of Regulatory Affairs with strong CMC experience for their New Jersey based office (relocation assistance provided if needed). This role has opened up because the team is rapidly growing and they are looking for someone with a technical background and generics experience to further encourage this growth.
This Manager of Regulatory Affairs position would be with global pharmaceutical company specializing in the development of generics, branded products, and OTC products, with a global presence in over 35 markets. They recently announced exclusive partnership to supply and commercialize five leading biosimilar candidates in Canada, as well as a license and distribution agreement to sell their generics portfolio in the MENA Region.
They are looking for someone with a strong CMC background and will enjoy the chance to work on the entire regulatory affairs life cycle, from pre-approval to post-approval. This will as a great position for someone who wants the opportunity to be able to take on a lot of variety in their responsibilities, wants to work on multiple product lines, and enjoys being provided the independence to approach these processes creatively in order to foster their growth.
QUALIFICATIONS:
* 4+ years of experience in Regulatory Affairs.
* Strong CMC experience.
* A background in the generics industry.
* Previous work with ANDA submissions.
* Previous management/mentor experience considered a plus.
RESPONSIBILTIES;
* Prepare new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings.
* Oversee a team of approximately 3 direct reports.
* Evaluate change management activities for commercial products.
* Provide suggestions for regulatory strategy that will ensure submission goals are met.
