Senior Regulatory Manager
4 days ago
We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. • Support product registrations, renewals & variations. • Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. • Respond to health authority queries in coordination with CMC, clinical, and quality teams. • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. • Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. • Experience working with local affiliates or partner companies in Emerging Markets. • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. • Experience with regional electronic submission platforms. Qualifications: • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field. • Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. • Knowledge of CTD structure, Module 1 customization, and regional submission formats. • Strong project management, communication, and stakeholder coordination skills
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Senior regulatory manager
3 weeks ago
Bangalore, India Biocon Biologics Full timeWe are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates,...
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Regulatory Reporting And Data Governance
3 weeks ago
Bangalore, Karnataka, India State Street Full timeBasic Purpose of Job The role will be responsible for the governance and oversight over regulatory reporting Some of the key responsibilities will include assisting process documentation enhancing internal controls implementing change management providing regulatory reporting focused training reporting issues and or reporting metrics to senior...
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Regulatory Affairs Officer
3 weeks ago
Bangalore, Karnataka, India IQVIA Full timeJob Overview Under general supervision Prepares and or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and or external clients Provides regulatory support for assigned projects Essential Functions Acts as a Regulatory Team Member on small straightforward regulatory projects...
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Senior Regulatory Affairs Trainer
7 days ago
bangalore, India Tek Support Full timeJob Title: Regulatory AffairsLocation: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for designing and...
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Senior Regulatory Affairs Trainer
7 days ago
bangalore, India Tek Support Full timeJob Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible...
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Senior Regulatory Affairs Trainer
6 days ago
bangalore, India Tek Support Full timeJob Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for...
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Manager global regulatory affairs
7 days ago
Bangalore, India Biocon Biologics Full timeJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...
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Manager Global Regulatory Affairs
2 weeks ago
Bangalore, India Biocon Biologics Full timeJob Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio ...
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Senior analyst
3 weeks ago
Bangalore, India Societe Generale Global Solution Centre Full timeRegulatory Reporting Responsibilities Responsibilities GBSU/REG Team deals with processes required to comply with various regional regulations in the OTC Derivatives space,for Ex.: DFA, EMIR, HKMA, MAS, Mi FID etc. REG Team carry out periodic post reporting controls to identify Regulatory reporting anomalies & rectify the issues in coordination with...
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Senior analyst
2 weeks ago
Bangalore, India Societe Generale Global Solution Centre Full timeRegulatory Reporting Responsibilities Responsibilities GBSU/REG Team deals with processes required to comply with various regional regulations in the OTC Derivatives space,for Ex.: DFA, EMIR, HKMA, MAS, Mi FID etc. REG Team carry out periodic post reporting controls to identify Regulatory reporting anomalies & rectify the issues in coordination with...
