Assistant Vice PresidentJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBAssistant Vice President
Cadila Pharmaceuticals Ltd
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Posted: 27 Feb 26
Job Description
Principal task and responsibilities :
• Submission of product dossiers for registration, in various countries including India as per the agreement with customers or as per the internal plan
• Submission of product dossiers for re-registration in various countries
• Submission of Clinical trial applications, variation applications in various countries; import/export permits, NOCs for BE studies
• Provide regulatory inputs in special projects, during development of product, variation submissions and commercial supplies as applicable.
• Gap analysis of product dossiers in existing markets for up gradation and submission of same in other markets. Develop regulatory defence mechanisms where needed.
• Serve as the key contact for regulatory agency, notified body and business partners.
• Develop and implement effective regulatory strategies to bring products to market and assessment of the probability of regulatory success for post-approval changes/commitments.
• Promote the development of a facility–wide understanding of the key elements related to quality system and regulatory compliance requirements.
• As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
• Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures.
• Review of technical/investigation reports, summaries for adherence to regulatory guidelines and to provide guidance to cross functional technical teams for the requirement and content of regulatory documentation.
• Evaluation of regulatory non-compliances and providing short term and long term mitigation measures
• Skill-development and coaching of regulatory and cross functional teams.
• Review and approval of investigation reports, deviations, change controls, CAPA for market complaints and other operational documents. Evaluation of technical agreements, due deligence of in-licensed dossiers, as needed.
• Steer regulatory audits and active participation in responding to inspectional observations, identification of CAPA, compliance enhancement plans and sustained compliance with GMP requirements
• Suggest resolution of post approval operational issues during manufacture of commercial batches and collaborate with multiple business partners as needed.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2849403
Job Category Regulatory Affairs
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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