Regulatory Author - HYBRID job in Cambridge, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Job type: Contract

Discipline: Consultant / Specialist, Publishing & Submissions, Operations

Location: United States

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 j.cerchio@proclinical.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.

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