This job offer is not available in your country.
Regulatory Affairs Manager
Right Advisors Private LimitedMumbai, Maharashtra, India2 days ago
Job descriptionProvide regulatory input to CMC data, BE & CT protocol, study waiver justification etc. Collaborate with other functions such as R&D, Quality, Supply chain, Project Responsible for end-to-end filing of New products(Drugs / Biologics / Biosimilars etc) to Well versed with filing application of ND / SND / FDC / Import Registration / Import licence Address queries from CDSCO / SFDA on submitted applications, provide regulatory Manage submission of application dossiers with relevant regulatory authorities, monitor Responsible for Subject expert committee (SEC) meetings including preparation of slide Provide Regulatory Support for timely new product launches
Experience- 10-12 Years
Location- Mumbai
Mandatory Skills- Regulatory Affairs, CDSCO,DCGI, SUGAM Portal
Only those candidates can apply whose salary is not more than 24 LPA
Looking from Only Pharma Companies
Key Accountabilities :
Propose efficient regulatory pathway for New Product Introduction
- Develop & implement regulatory strategies for new / generic product registrations in
compliance with relevant regulations and the business needs
related to new products filing
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
etc on SUGAM portal
support for IPC / CDTL / CDL testing
the review process and take appropriate actions to obtain regulatory approvals as planned.
deck in co-ordination with cross functional teams and SEC deliberation
Track all SEC meetings to identify and recommend new product ideas / opportunities
aligned with current business needs
Minimum Education : M. Pharm / B. Pharm
Interested candidates please share their resume on sudha.kumari@rightadvisors.com.
Create a job alert for this search
Manager • Mumbai, Maharashtra, India
Related jobs
As a Manager - Corporate Affairs, you will support government relations, engage with policymakers and.Maharashtra, and execute strategies to drive business growth, working closely with the Group.Pr...Show moreLast updated: 30+ days ago
Regulatory Expertise : Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.
Dossier Management : Compile and review ACTD and CTD dossiers to ensure acc...Show moreLast updated: 3 days ago
Regulatory Affairs
J D HEALTHCARE LIMITEDMumbai Suburban, Maharashtra, India JD Lifesciences, operating under J D HEALTHCARE LIMITED,.We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the countr...Show moreLast updated: 26 days ago
Senior Executive - Regulatory Affairs Labelling
Piramal GroupMumbai, Maharashtra, India Business : Piramal Critical Care Department : Regulatory Affairs Location : Kurla Travel : Low.Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adhe...Show moreLast updated: 18 days ago
Manager- Corporate Affairs
ScaleneWorksMumbai, Maharashtra, IndiaQuick Apply
Sr. Manager Regulatory Affairs
AMGENINDIA The RA CMC Senior Manager is responsible for execution and / or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execu...Show moreLast updated: 30+ days ago
Regulatory Affairs Manager I
ASTRAZENECAINDIA Job Title : Regulatory Affairs Manager I.The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordinatio...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist
MEDTRONICINDIA At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
Youll lead with purpose, breaking down barriers to innovatio...Show moreLast updated: 30+ days ago
- Promoted
Snapmint - Legal Counsel - FinTech / Commercial / Regulatory Affairs - LLB / LLM
SnapmintMumbai, India About Snapmint : Snapmint is a leading fintech company redefining access to consumer credit in India.Backed by marquee venture capital and private equity investors, our zero-co...Show moreLast updated: 12 days ago
- Promoted
Manager - Legal (Audit Regulatory)
BDO in IndiaMumbai, Maharashtra, India BDO is a global network of professional services firms with a presence in over 166 countries, revenue of over USD 14 billion, and experience of over 60 years.
It’s a leading service provider for the...Show moreLast updated: 18 days ago
- Promoted
Antier - Head - Crypto Compliance & Regulatory Affairs
Antier Solutions Private LimitedPunjab, India About Antier Solutions Antier Solutions is a global leader in blockchain, DeFi, and tokenization , driving regulatory-compliant Web3 innovations.As ...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Affairs Manager
Right Advisors Private LimitedMumbai, Maharashtra, India Mandatory Skills- Regulatory Affairs, CDSCO,DCGI, SUGAM Portal.Only those candidates can apply whose salary is not more than 24 LPA.
Looking from Only Pharma Companies.Propose efficient regulatory p...Show moreLast updated: 2 days ago
- Promoted
Regulatory Affairs Associate III
Teva PharmaceuticalsMumbai, Maharashtra, India Work location : Mumbai & Bangalore.Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and / or 505(b)(2)s, if required, and for early development ...Show moreLast updated: 26 days ago
Manager Regulatory Affairs
AbbottMumbai, Maharashtra, India The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and draft...Show moreLast updated: 6 days ago
- Promoted
Senior Executive - Regulatory Affairs (Finished Oncology Products)
Smart Moves ConsultantsMumbai, Maharashtra, India Candidate should be from RA, and actively involved in regulatory affairs function on finished dosage form.Sound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC / s...Show moreLast updated: 13 days ago
- Promoted
Regulatory Affairs Manager
Domnic LewisMumbai, Maharashtra, India Opportunity for the position of.Location : Worli - Prabhadevi, Mumbai.Designation : AM / Manager- Regulatory.To compile and submit the dossiers for APAC, ROW, LATAM markets.Preparation of dossiers is...Show moreLast updated: 2 days ago
Assistant Manager – Regulatory Affairs
AstraZenecaMumbai,India AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s mo...Show moreLast updated: 6 days ago
Director Regulatory Affairs
Michael PageMumbai Suburban Be part of fastest growing medical AI company success story.Be the primary liaison for quality system management and regulatory affairs.
Fast growing medical AI company developing cutting edge solut...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist
Jobskey ConsultancyMumbai, Maharashtra, IndiaQuick Apply
- Promoted
Wockhardt - Regulatory Affairs Manager
Wockhardt LimitedMaharashtra, India Company Description Wockhardt Ltd.Headquartered in Mumbai, India, Wockhardt has a multi-ethnic workforce of 3000 associates across 21 nationalities.The company opera...Show moreLast updated: 30+ days ago