CMC Regulatory Affairs Manager
CMC Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Lead the preparation review and submission of CMC sections of regulatory filings (e.g. INDs NDAs BLAs MAAs variations renewals) to global health authorities ensuring accuracy completeness and compliance with applicable regulations and guidelines.
- Provide regulatory guidance and support to crossfunctional teams throughout the product development lifecycle including manufacturing process development technology transfer scaleup validation and postapproval changes.
- Interpret and communicate regulatory requirements guidelines and expectations related to CMC to internal stakeholders ensuring alignment with global regulatory strategies and objectives.
- Proactively identify regulatory risks opportunities and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
- Collaborate with internal stakeholders including Manufacturing Quality Assurance Quality Control Supply Chain and Clinical Development to ensure regulatory compliance and alignment with business objectives.
- Establish and maintain positive relationships with regulatory agencies and industry peers representing the company in regulatory interactions meetings and negotiations as needed.
- Stay abreast of emerging regulatory trends changes and developments related to CMC and communicate potential impacts to relevant stakeholders.
Requirements:
- Bachelors Masters or Ph.D. degree in Pharmacy Chemistry Pharmaceutical Sciences or related scientific discipline.
- 57 years of experience in regulatory affairs CMC in the pharmaceutical industry.
- Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g. INDs NDAs BLAs MAAs IMPDs) and interacting with global health authorities (e.g. FDA EMA Health Canada PMDA).
- Strong understanding of global regulatory requirements guidelines and expectations related to CMC for pharmaceutical products (e.g. ICH guidelines FDA regulations EudraLex).
- Excellent communication collaboration and project management skills with the ability to effectively interact with crossfunctional teams and external stakeholders.
- Proven ability to prioritize tasks manage multiple projects simultaneously and meet deadlines in a fastpaced dynamic environment.
- Detailoriented mindset with a focus on quality accuracy and compliance.
- Experience with regulatory submissions for small molecules biologics or other pharmaceutical modalities is preferred.
- Regulatory Affairs Certification (RAC) is a plus.
Employment Type
Full Time
