Regulatory Affairs Consultant

Parexel • Newton, MA • 12h ago

Job Location: 275 Grove Street, Suite 101C, Newton, MA 02466. Position may telecommute from anywhere in the United States up to 5 days per week.

Job Title: Regulatory Affairs Consultant

Duties: Parexel International LLC seeks a Regulatory Affairs Consultant reporting to headquarters based in Newton, Massachusetts to prepare clinical and regulatory documentation for clinical trials. Deliver consulting services to ensure that the company meets regulatory requirements. Author MRLs, Briefing Books, New INDs, Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, and NDA/BLA submissions. Provide regulatory consulting services and project management in a pharmaceutical setting to identify, refine, and address client issues and achieve project objectives. Provide guidance to project team members on technical/ regulatory process issues and ensure timely work performance within project scope to meet internal and external quality expectations. Interpret data and advice from regulatory authorities across all phases of the drug development process, including projects with no precedence. Work within the FDA Act section 505(b)(2) pathway drug approval process. Identify and alert management to necessary changes in project scope. Build network of industry colleagues through relationships formed during project engagements. Communicate potential new business leads to line management and account managers. Position may telecommute from anywhere in the United States up to 5 days per week. (Ref. # 00941) Annual salary: $111,904 - $173,451.

Requirements: PhD in Microbiology, Immunology, Molecular Biology, or a related field plus six months of clinical regulatory experience. Must have at least six months of experience in each of the following: (1) project management in a pharmaceutical setting; (2) consulting on clinical regulatory compliance; (3) interpreting data and advice from regulatory authorities; (4) regulatory affairs work across all phases of the drug development process, including projects with no precedence; (5) authoring MRLs, Briefing Books, New INDs, Fast Track Applications, Orphan Drug Applications, and responses to FDA requests; and (6) the FDA Act section 505(b)(2) pathway drug approval process.

To apply, please send resume to openings@parexel.com and cite requisition number 00941, or apply at jobs.parexel.com. This position is subject to the company's Employee Referral Program.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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