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.
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 [email protected] 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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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
