Senior Regulatory Associate - Hybrid, NJ (2-3 days a week)
I am currently partnered with a global commercial pharmaceutical company that is passionate about bringing generic drugs to market across multiple formulations and dosage forms.
They are continuing to expand and are seeking an Associate Manager or Manager to join their team. This is a hybrid role based in New Jersey (2-3 days a week onsite), offering a fantastic opportunity to work on diverse projects.
In this role, you will be the Regulatory lead for submission planning and strategy for development projects and existing FDA-approved products.
You will be expected to prepare high-quality ANDA submissions (including amendments, supplements, and Annual Reports) with the support and oversight of the Senior Manager / Associate Director of Regulatory Affairs.
Responsibilities :
- Act as the Regulatory Affairs lead on assigned projects, ensuring the completion, accuracy, and content of eCTD submissions (ANDAs, Supplements, Amendments, and Annual Reports).
- Maintain and update senior Regulatory Affairs management on critical project developments and their potential impact on regulatory submissions, highlighting any challenges or issues that might arise during an FDA review.
- Collaborate with different stakeholders across the company and procure documentation required for regulatory submissions, ensuring that departmental timelines are met.
- Support the creation and review of technical documents for accuracy and acceptability for use in new ANDAs, Amendments, Supplements, Annual Reports, and other required FDA filings to ensure high-quality submissions and prompt approvals from the FDA.
- Review and approve change controls and assess their impact on the business based on an advanced understanding of regulatory guidelines and applicable FDA laws.
Qualifications and Experience :
Education : Minimum of a bachelor’s degree in a life science, pharmacy-related curriculum, and / or an advanced degree related to Manufacturing, Chemical, Pharmaceutical, or Biological Sciences.
RAC Certification is a plus)
- Experience : 2+ years in the generic pharmaceutical industry, ideally in Regulatory Affairs.
- Specific Knowledge : General practices in Regulatory Affairs for generic drugs and FDA guidelines.
- Travel : 5% (potential overseas travel to visit manufacturing sites / CMOs or CROs).
Apply today to learn more or send me an email to [email protected]
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