Regulatory Affairs Consultant

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.

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.

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.

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