Regulatory Author - HYBRID

Highly Competitive Salary
  1. Contract
  2. Consultant / Specialist, Publishing & Submissions, Operations
  3. United States
Cambridge, USA
Posting date: 19 Sep 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a hybrid Regulatory Author for a global biopharmaceutical company located in Cambridge, MA.

The Regulatory Author plays a crucial role in the Company's regulatory endeavors concerning new and existing products, both domestically and internationally.

Must be eligible to work in the US.

Job Responsibilities:

  • Writing regulatory documents for initial filings, life cycle variations, and supplements across all target markets.
  • Writing summary reports of process development
  • Assisting in updating laboratory records and protocols
  • Preparing well-informed responses to inquiries from Regulatory Authorities on matters pertaining to regulatory documents, including non-clinical, epidemiological, and safety aspects.
  • Collaborating with various departments involved in the writing and review process of regulatory documents.

Skills and Requirements:

  • Degree in Life Sciences
  • At least 3 years of experience in scientific writing within the pharmaceutical industry, including regulatory documents for EU, US, or international markets.
  • PhD in life sciences
  • Proficiency in regulatory procedures, systems, and guidance related to regulatory document submissions.
  • In-depth understanding of relevant regulatory guidance (e.g., ICH, WHO, etc.).
  • Proficient in spoken and excellent in written English.
  • Experience working with Biologics.
  • Demonstrates critical, analytical, and synthetic abilities.
  • Capable of managing time efficiently to meet short-term targets.
  • Exhibits a collaborative and adaptable approach to working under pressure and time constraints.
  • Actively seeks feedback on performance to drive continuous improvement.
  • Strong scientific writing skills to convey complex information clearly and concisely in regulatory documents.
  • Ensures coherence between contributions, ensuring the quality of final results.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.