Regulatory Affairs CMC SpecialistÂ
Regulatory Affairs CMC SpecialistÂ
Posted on :
18-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Prepares and/or coordinate CMC activities for new product registrations post approval changes renewals annual reports and extension applications ensuring on-time and high-quality global submissions.
- Interface with external Contract Manufacturing Organizations (CMO) and relevant functional teams in obtaining the necessary CMC documentation in support of a regulatory submission.
- Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed.
- Reviews and assesses change control requests pertaining to CMC aspects of GRD products and coordinates filing strategies with minimal assistance; attend change control meetings as regulatory-CMC representative.
- Maintain submission information according to the document management system track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
- Maintain sound knowledge of regulations policies/guidelines and keep abreast with current and evolving regulatory CMC requirements.
- Participate in ad-hoc or special regulatory projects as needed.
- Minimum of a bachelors degree in a relevant field (e.g. Life Sciences Pharmacy Chemistry).
- Pharmaceutical Regulatory Affairs certification preferred.
- 2 years of experience in Regulatory Affairs specifically with Small Molecules focused on Regulatory CMC.
- Good understanding of the drug development and life-cycle management process.
- Familiarity with global CMC regulations including ICH requirements and US/EU and Health Canada regulatory guidances.
- Experience in authoring technical documents CTD M2 and M3 sections and life cycle management of quality variations/supplements.
- Strong oral and written communication skills with superior attention to detail.
- Demonstrates initiative and is proactive; ability to work independently and within a team setting.
- Proficiency in Microsoft Office programs and other regulatory databases (e.g. Track wise Veeva eCTD publishing software).
Employment Type
Full Time
Key Skills
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