Formulation Regulatory Affairs
2 weeks ago
Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on life cycle management for the products filed in US market. Comprehensive and up-to-date knowledge on regulatory guidelines/requirements. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing. Responsible to understand the requirements related to US regulatory submissions. Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received. Publishing the necessary regulatory dossiers into eCTD format as per the country requirement. Review of technical (developmental and plant) documentations required for dossier submission. Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com Required skills :- Hands on ANDA/ANDS Filing expertise A stable candidate from Pharma company Should have exp of US Submissions Well versed with regulatory guidelines. Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com Kindly mention below details while sharing CV : Total Exp Current CTC Total number of ANDA/ANDS filings, Notice Period Ok for Bangalore onsite job. (5 Days working)
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Formulation Regulatory Affairs
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Formulation Regulatory Affairs
2 weeks ago
Bangalore City, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Formulation Regulatory Affairs
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...
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Formulation Regulatory Affairs
1 month ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on life...
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Formulation regulatory affairs
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs. Qualification: - M. Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and...
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Formulation regulatory affairs
7 days ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs. Qualification: - M. Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on...
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Formulation Regulatory Affairs
1 month ago
Bangalore City, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...
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Formulation Regulatory Affairs
1 week ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules....
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Formulation Regulatory Affairs
7 days ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules....
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Formulation Regulatory Affairs
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Formulation Regulatory Affairs
1 month ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on...
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Manager global regulatory affairs
2 weeks ago
Bangalore, India Biocon Biologics Full timeRegulatory Affairs Manager Bangalore, India Job Description: Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones) Accountable for development and execution of...
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Manager Global Regulatory Affairs
2 weeks ago
bangalore, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)Accountable for development and execution of CMC...
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Regulatory Affairs Manager I
5 months ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The...
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National head regulatory affairs
2 weeks ago
Bangalore, India Syngene International Limited Full timeThe Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398 R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to...
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Lead Regulatory Affairs
1 month ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...
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National Head Regulatory Affairs
2 weeks ago
bangalore, India Syngene International Limited Full timeThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to...
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Regulatory Affairs Manager I/II
4 months ago
Bangalore, India AstraZeneca Full timeJOB TITLE: Regulatory Affairs Manager I/II CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping...
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Manager global regulatory affairs
2 weeks ago
Bangalore, India Biocon Biologics Full timeAssistant Manager Global Regulatory Affairs Bangalore, India Job Description: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets. Biosimilars or injectables experience is mandatory for this role . Responsible for : Development and...
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Manager Global Regulatory Affairs
2 weeks ago
bangalore, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.Biosimilars or injectables experience is mandatory for this role.Responsible for:Development and Implementation of...