Regulatory Affairs Specialist

The Regulatory Affairs Specialist will focus on the coordination and documentation of the internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. In addition, the RA Specialist will compile and prepare materials for submission to regulatory agencies

Position Title: Regulatory Affairs Specialist Department: Quality/Regulatory
Reports To: SR. Director RA, QA & Pharmacovigilance Work Location: East Brunswick, NJ

Position Summary:

Provide an overview of the role, including job scope/responsibilities, impact, decision authority, problem-solving, level of influence, etc.

Essential Duties & Responsibilities: Rising owned ANDAs

Independently draft, review, compile and publish ANDA submissions in eCTD format.

Draft, review, compile and publish CMC post-approval submissions like supplements (PAS, CBE-30, and CBE), annual reports, and PADER’s

Troubleshooting validation errors prior to the ANDA, SPL, and supplement submissions

Drafting deficiency letter responses and coordinating with cross-functional teams to obtain accurate documentation. Responsible for assembly of ANDA submissions working directly with CMO’s and development partners.

Evaluating change controls and providing regulatory assessment in Track-wise system/ Quality Assurance Management System

Drug Master File review during the pharmaceutical drug development

Applying knowledge of ICH, USP (United States Pharmacopeia) /Eu Ph. (European Pharmacopeia) and 21 Code of Federal Regulations (21 CFR) on various submissions

Communicating with USFDA/ Health Authority on the status of the submissions

Track Regulatory activities via project management tools such as Excel, MS project, etc

Organize and update Regulatory files in internal drives.

Responsible for labeling generation including inserts, container and carton labels, patient brochures, etc., and Labeling submissions to FDA

Responsible for preparation of post-marketing reporting such as 15-Day MEd Watch’s, Periodic Safety Reports, compiling relevant information provided by partners and CMO’

Responsible for compiling information required for a drug listing.

Communicate and provide information to partners upon request. Provide presentation material for management updates.

Partner owned ANDAs: * Communicate and provide information to partners upon request

Partner owned ANDAs: * Work closely with partners and CMO’s for labeling development and review.

Position Requirements:

Required: Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science
Required: 8-10 years’ experience within the pharmaceutical industry with a minimum of 5+ years in Regulatory Affairs
Specialized Training or Technical Knowledge Licenses, Certifications Needed:
• Knowledge and comprehension of Code of Federal Regulations requirements (21CFR 211 GMP’s 21CFR 201 Labeling and 21 CFR 314 ANDA’s)

• Knowledge and comprehension of applicable FDA regulatory guidelines and compendia requirements

Company / Industry Related Knowledge:
Pharmaceutical knowledge

Job Specific Competencies:

• Working knowledge of MS Word, Excel, Outlook, and PowerPoint and Adobe Illustrator or equivalent
• Excellent communication and interpersonal skills

Physical Requirements:


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