▷ 3 Days Left: Regulatory Affairs Specialist
4 weeks ago
Role - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Exp: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibilities: - Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables. - Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products. - Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements. - Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Ensure to respond within the prescribed timelines. - Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. - Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head. - Any other responsibilities vested by reporting head based on requirements. Required skills :- - Hands on expertise of handling Peptide or Injectable products. - Peptide Regulatory Exp will be prefered more. - Well versed with regulatory guidelines. Candidates with relevant exp., kindly share CVs to apply on :- Kindly mention below details while sharing CV :- - Total Exp? - Current CTC? - Handling exp of Peptide Regulatory or not? - Notice Period? - Ready to work in Bangalore (onsite) ? (5 Days working)
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Regulatory Affairs Specialist
1 week ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:- Drafting controlled correspondences, pre-development meetings...
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Regulatory Affairs Specialist
2 weeks ago
Bangalore, India NexorTest Technologies Full timeLocation: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...
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International Regulatory Affairs Manager I
1 week ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in...
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Regulatory Affairs Manager
5 days ago
bangalore, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Manager
4 days ago
bangalore, India beBeeRegulatoryAffairs Full timeWe are seeking an experienced professional to join our team as a Regulatory Affairs Manager.The ideal candidate will have 8-12 years of experience in regulatory affairs and a strong understanding of the MENA region.Key responsibilities include:Planning and maintaining client product portfoliosCompilation, review, and submission of registration...
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Regulatory Affairs Specialist
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Specialist
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Associate
14 hours ago
Bangalore, Karnataka, India Anrgi Tech Full timeJob Title Regulatory Affairs Associate - Authoring Role detailed classification Regulatory Affairs Authoring Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - Authoring to join our LS Practice team The successful candidate will be responsible for LS Regulatory Authoring and or other assigned RA...
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Regulatory Affairs Manager
5 days ago
bangalore, India Ixoreal Biomed Full timeAbout the Company:Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Scientific and Regulatory Affairs Consultant
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...
