Regulatory Affairs Consultant

Parexel•Newton, MA

14d•Remote

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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.

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.

Responsibilities

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.