Regulatory Associate
ABOUT US: Luitpold Pharmaceuticals, Inc. is a leading pharmaceutical company manufacturing both generic and brand name products.
Luitpold Pharmaceuticals, Inc. is located on Eastern Long Island.
Luitpold is comprised of 3 divisions: American Regent.
- Manufactures and distributes quality injectable products used in healthcare facilities, including Venofer, the #1 selling IV iron product in the United States.
Luitpold Animal Health - Manufactures and markets pharmaceutical products for the treatment of degenerative joint disease for horses and osteoarthritis in dogs.
Osteohealth Co. is Luitpold's cutting-edge biotechnology division.
It currently markets products used in dental bone grafting and guided bone regeneration.
Luitpold also has made a significant investment through the Osteohealth Division to the research and development of tissue engineering products.
Are you truly committed to superior quality, as well as an innovative working environment? Then, come join the Luitpold team! We continue to invest heavily in research and development in all divisions, and we are always looking for experienced, high-energy, professional candidates to join our growing company.
Luitpold Pharmaceuticals offers a complete benefits package, which includes medical and dental coverage, vision plan, 401 (k) plan with company match, profit-sharing plan, tuition reimbursement, flexible spending plan, free life insurance, long-term disability, service awards and annual holidays.
Why wait? It is an exciting time at Luitpold, so come join us as we continue to grow our team.
Regulatory Associate RESPONSIBILITIES: Prepare submissions to regulatory agencies.
Responsible for cGMP compliance.
Prepare customer's requests for certificates to FDA. Review and submit promotional/advertising material to FDA. Prepare Annual Product Review Forms for all ANDA/NDA/NADA/NDS products.
Prepare PSUR's for various foreign companies.
Responsible for post-marketing reporting (Annuals, DMFs, ADEs, SMFs).
Knowledge and comprehension of Code of Federal Regulations (21, 29 & 40 CFR).
Knowledge and comprehension of various FDA regulatory guidelines.
Knowledge of USP and supplements.
JOB REQUIREMENTS: Associates degree preferred.
4-5 years experience within the pharmaceutical industry.
Word processing required.
We offer a competitive salary/benefits package including medical dental, vision, 401K & profit sharing plans.
Send resume with salary requirements to resumes [at] luitpold [dot] com or FAX to: 631.
924.8654. We are an equal opportunity employer committed to diversity in the workplace.
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