July 1, 2020

Regulatory Affairs Specialist - Laurelton, NY

DESCRIPTION:

Regulatory Affairs Specialist wanted for Epic Pharma, LLC in Laurelton, New York, with Master’s Degree in Pharmaceutical Chemistry or Chemistry and at least one year of experience in the pharmaceutical industry with knowledge of FDA regulations, to perform the following job duties:

 

 • Prepare, compile and review Regulatory filings including new ANDA/NDA submissions, Amendments, Supplements, Annual Reports, Safety Reports.

 • Acquire and review required scientific and technical documentation for all types of regulatory submissions; ensure that all regulatory submittals are comprehensive, timely and accurate, and are compliant with U.S. regulations and guidance; maintain records regularly.

 • Critically evaluates the regulatory acceptability of proposed drugs and labelling.

 • Review ingredient and product information including, but not limited to, ingredient specifications, marketing/sales literature, labeling and advertising materials for regulatory compliance; analyze and recommend appropriate changes internally and externally for the suppliers and clients.

 • Review and communicate emerging regulatory requirements to ensure compliance.

 • Interface with external CMOs, and other regulatory groups/sites as well as regulatory agencies regarding pre-submission strategies, potential regulatory pathways and obstacles, submission review follow-ups involving chemical properties of the pharmaceutical drugs, etc. 

 • Participate in product team meetings; Provide regulatory support and guidance and manage day-to-day regulatory activities; ensure regulatory timelines are met as per FDA guidelines.

 • Ensure product safety issues and product-associated events are reported to regulatory agencies

 

Please mail resume to Epic Pharma, LLC. 227-15 N. Conduit Avenue, Laurelton, NY 11413

 

March 13, 2020

Chemist - Laurelton, NY

DESCRIPTION:

Analytical research and development, including analytical method development for assay, related compounds, dissolution for raw materials, in-process and finished products.  Carry out method transfer and method validation.  Draft validation protocols and reports.  Work with different formulation types including tablets, capsules, soft gels, topicals and suspensions.  Provide formulation support for research and development where required.

 

REQUIRES:

Bachelor’s Chemistry + minimum 1 year experience as Chemist, ARD Scientist, Principal Scientist or related.

 

 

 

 

 

Send resumes to:

                       Epic Pharma, 227-15 N. Conduit Avenue, Laurelton, NY 11413

                       Email: hr@epic-pharma.com

 

 

Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package including medical/dental/vision/401k.