Regulatory Affairs Consultant
Share
Job Location:
Newton, MA - USA
Monthly Salary:
$ 111904 - 173451
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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.
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: $111904 - $173451.
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 and cite requisition number 00941 or apply at . This position is subject to the companys 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.
Required Experience:
Contract
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
