Job Description
Requirements:
At least: 4 years regulatory experience with novel drugs (small molecules and biologics). Experience with combination drug/devices products preferred.
At least: 5 years pharmaceutical/biotech industry experience
Minimum: Masters in in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, Chemical Engineering or other relevant scientific training.
Job Description:
Sun Pharma is looking for a creative and flexible individual with strong spoken and written communications skills and is able to navigate in a diverse cross cultural cross functional environment.
Experience in developing regulatory CMC strategies to support novel drugs and biologics from inception through post-approval on a global basis. Any experience with combination drug/devices is preferred.
Experience in reviewing CMC manufacturing and developmental processes to insure a compliant and complete regulatory dossier.
Experience in regulatory agency audits and pre-approval inspections.
A strong understanding of global CMC regulatory and quality requirements (FDA, CFR, EU Directives, ICH, ISO, USP, EP, JP, and applicable national requirements) for developing new drugs/biologics and has the understanding and ability to acquire needed regulatory intelligence to support programmatic needs.
Ability to author the creation of clear and concise regulatory CMC documents including but not withstanding:
o Meeting briefing documents
o INDs, CTA, IMPD, MAA, NDA, BLA, 510(k), PMA sections as required
Experience in oversight of the regulatory CMC aspect of programs that lead to successfully gaining approval and/or clearances of INDs, CTAs, NDA, MAA, BLA, IDE, 510(k), PMA
Experience in actively leading in meetings with regulatory agencies on CMC issues and has worked closely with regulatory agencies to resolve program specific developmental issues.
Must work closely with the regulatory lead strategist and overall development team to insure regulatory CMC strategy and execution is aligned with overall development program.
Strong project management skills and interpersonal skills to handle complex distributed programs
Willingness and openness to learn new regulatory skills to support development programs.
Travel: 10% of time.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Regulatory Affairs Manager
Role: Regulatory Affairs Manager
At least: 4 years regulatory experience with novel drugs (small molecules and biologics). Experience with combination drug/devices products preferred.
At least: 5 years pharmaceutical/biotech industry experience
Minimum: Masters in in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, Chemical Engineering or other relevant scientific training.
Job Description:
Sun Pharma is looking for a creative and flexible individual with strong spoken and written communications skills and is able to navigate in a diverse cross cultural cross functional environment.
The candidate must have:
Experience in developing regulatory CMC strategies to support novel drugs and biologics from inception through post-approval on a global basis. Any experience with combination drug/devices is preferred.
Experience in reviewing CMC manufacturing and developmental processes to insure a compliant and complete regulatory dossier.
Experience in regulatory agency audits and pre-approval inspections.
A strong understanding of global CMC regulatory and quality requirements (FDA, CFR, EU Directives, ICH, ISO, USP, EP, JP, and applicable national requirements) for developing new drugs/biologics and has the understanding and ability to acquire needed regulatory intelligence to support programmatic needs.
Ability to author the creation of clear and concise regulatory CMC documents including but not withstanding:
o Meeting briefing documents
o INDs, CTA, IMPD, MAA, NDA, BLA, 510(k), PMA sections as required
Experience in oversight of the regulatory CMC aspect of programs that lead to successfully gaining approval and/or clearances of INDs, CTAs, NDA, MAA, BLA, IDE, 510(k), PMA
Experience in actively leading in meetings with regulatory agencies on CMC issues and has worked closely with regulatory agencies to resolve program specific developmental issues.
Must work closely with the regulatory lead strategist and overall development team to insure regulatory CMC strategy and execution is aligned with overall development program.
Strong project management skills and interpersonal skills to handle complex distributed programs
Willingness and openness to learn new regulatory skills to support development programs.
Travel: 10% of time.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Regulatory Affairs Manager
Role: Regulatory Affairs Manager
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