AddressWho we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Regulatory Affairs Associate II is responsible for the supporting the development, coordination and implementation of regulatory strategies within the Immunology Therapeutic Area. The successful candidate will be able to prepare high quality regulatory submissions and work in a collaborative environment in the support of products in clinical development or marketed.
Travel Requirements: none
Location: On-Site in West Chester, PA (Hybrid schedule)
RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE
How you’ll spend your day
- Responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements
- Participates in cross functional teams including Global Regulatory Team, Clinical Development Team and Project teams
- With support from the supervisor, coordinate in planning, preparation, and execution of Health Authority meetings. Also, interact with the FDA regarding pre-clinical and clinical development issues and provide support to our ex-US Regulatory counterparts regarding preclinical and clinical support, as needed
- Ensure the preparation of INDs, NDAs, sNDAs, BLAs, and MAAs including liaising with U.S. and ex-U.S. regulatory personnel as required. Conduct gap analyses in a timely manner. Oversee the maintenance of INDs and NDAs, and ex-U.S. filings as required.
- Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
Your experience and qualifications
Required:
- Bachelor’s Degree in scientific field or equivalent combination of education and related work experience.
Preferred:
- PharmD, PhD, or Master’s degree
- Experience in Pharmaceutical, Research or Pharmacy Field
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance
Reports To
Director Regulatory Affairs
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