Regulatory Author - HYBRID
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.
- 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 email@example.com.
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.