Executive, Regulatory Affairs
Found in: beBee S IN - 2 weeks ago
Overall purpose of job:
• Regulatory compliance for the Medical Devices marketed by Johnson & Johnson MedTech India
• To maintain the Life cycle management of the product registered by Johnson & Johnson
• Coordinate with internal stakeholders to Developed regulatory strategies and mitigate interdependencies of overlapping projects to successfully submit application.
Essential duties and responsibilities:
• Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India market.
• Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India market in accordance with applicable regulations and relevant guidelines.
• Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
• Update and live maintenance of business plan in sharepoint for assigned franchises/ licenses.
• Assist in the preparation of technical presentations/ meetings with regulator.
• Gathers and assembles information, prepares documents for New Product applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines.
• Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management)
• Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/franchises.
• Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
• Maintenance of RA database for the responsible franchises in MDRIM tool.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.
• Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.
• Ensure on time archival of regulatory submission documents.
• Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.
• Other assignment identified and assigned by Supervisor/ management- time to time.
Special requirements:
• Knowledge of Medical Device Rule 2017 and Drugs and Cosmetics Act
• Knowledge in the international regulations of Medical Devices in US and EU
• Excellent proficiency with software tools
Job location:
Gurgaon, Haryana- India
-
Executive, Regulatory Affairs
Found in: Whatjobs IN C2 - 7 days ago
gurugram, India Johnson and Johnson Full timeJob title: Executive, Regulatory Affairs Overall purpose of job: • Regulatory compliance for the Medical Devices marketed by Johnson & Johnson MedTech India • To maintain the Life cycle management of the product registered by Johnson & Johnson • Coordinate with internal stakeholders to Developed regulatory strategies and mitigate...
-
Sr. Executive, Regulatory Affairs
Found in: Whatjobs IN C2 - 1 week ago
gurugram, India Johnson and Johnson Full timeJob title: Sr.Executive, Regulatory Affairs Overall purpose of job: • Regulatory and quality compliance for the entire Johnson & Johnson Medical franchises in India • To maintain the Life cycle management of the product registered by Johnson & Johnson • Developed regulatory strategies along with internal stakeholders to coordinate...
-
Senior Manager Regulatory Affairs Agrochemical
Found in: Whatjobs IN C2 - 1 week ago
gurugram, India Om Sai Global HR Service Full timeJob Title: Senior Manager Regulatory Affairs Agrochemical Experienc: More then 10+ years Location: Gurgaon Job Overview We are seeking a highly experienced Senior Manager Regulatory Affairs Agrochemical to join our team at Om Sai Global HR Service. As the Senior Manager Regulatory Affairs Agrochemical, you will be responsible for overseeing all...
-
Senior Manager Regulatory Affairs Agrochemical
Found in: Talent IN C2 - 2 weeks ago
Gurugram, India Om Sai Global HR Service Full timeJob Title: Senior Manager Regulatory Affairs Agrochemical Experienc: More then 10+ yearsLocation: Gurgaon Job OverviewWe are seeking a highly experienced Senior Manager Regulatory Affairs Agrochemical to join our team at Om Sai Global HR Service. As the Senior Manager Regulatory Affairs Agrochemical, you will be responsible for overseeing all regulatory...
-
Senior Officer
Found in: Whatjobs IN C2 - 1 week ago
gurugram, India Om Sai Global HR Service Full timeJob Overview We are seeking a skilled and experienced Senior Officer - Regulatory Affairs (Agrochemical) to join our team at Om Sai Global HR Service. As a Senior Officer, you will be responsible for managing all aspects of regulatory compliance for our agrochemical products. This includes ensuring that our products meet all necessary regulatory...
-
Senior Officer
Found in: Talent IN C2 - 2 weeks ago
Gurugram, India Om Sai Global HR Service Full timeJob OverviewWe are seeking a skilled and experienced Senior Officer - Regulatory Affairs (Agrochemical) to join our team at Om Sai Global HR Service. As a Senior Officer, you will be responsible for managing all aspects of regulatory compliance for our agrochemical products. This includes ensuring that our products meet all necessary regulatory requirements...
-
Sr. Executive, Regulatory Affairs
Found in: beBee S IN - 2 weeks ago
Gurugram, India Johnson & Johnson Full timeJob title: Sr. Executive, Regulatory Affairs Overall purpose of job: • Regulatory and quality compliance for the entire Johnson & Johnson Medical franchises in India • To maintain the Life cycle management of the product registered by Johnson & Johnson • Developed regulatory strategies along with internal stakeholders to coordinate and...
-
Regulatory Affairs Executive
Found in: Whatjobs IN C2 - 2 weeks ago
Gurugram, India ib vogt GmbH Full timeThe new sustainability: want to join a renewable energy pioneer? Our mission is to advance large-scale photovoltaics to meet the growing global demand for clean electricity. Come be a part of our success story! Regulatory Affairs – (Executive) (m / f / d) Full-time employee, Gurugram Profile Summary: We are developing solar, wind and solar-wind hybrid...
-
Regulatory Affairs Executive
Found in: Appcast Linkedin IN C2 - 3 weeks ago
Gurugram, India ib vogt GmbH Full timeThe new sustainability: want to join a renewable energy pioneer? Our mission is to advance large-scale photovoltaics to meet the growing global demand for clean electricity. Come be a part of our success story!Regulatory Affairs – (Executive) (m / f / d)Full-time employee, GurugramProfile Summary:We are developing solar, wind and solar-wind hybrid sites...
-
Regulatory Affairs Executive
Found in: Talent IN 2A C2 - 2 weeks ago
Gurugram, India ib vogt GmbH Full timeThe new sustainability: want to join a renewable energy pioneer? Our mission is to advance large-scale photovoltaics to meet the growing global demand for clean electricity. Come be a part of our success story!Regulatory Affairs – (Executive) (m / f / d)Full-time employee, GurugramProfile Summary:We are developing solar, wind and solar-wind hybrid sites...
-
Senior Manager Regulatory Affairs
Found in: Whatjobs IN C2 - 1 week ago
gurugram, India Om Sai Global HR Service Full timeJob Overview We are seeking a highly experienced and knowledgeable Senior Manager Regulatory Affairs - Agrochemical & International Registration to join our team. As the Senior Manager Regulatory Affairs, you will be responsible for overseeing all regulatory compliance and strategy related to agrochemical products. This is a senior leadership role that...
-
Regulatory Affairs SSC Team Lead(Biopharma)
Found in: Whatjobs IN C2 - 1 week ago
gurugram, India Michael Page Full timeOpportunity to work with a leading pharmaceutical Company A great role to lead a team of Regulatory Affairs Associates About Our Client Our client is a leading global healthcare company providing a diverse range of products in pharmaceuticals and Medical devices. They are a leading healthcare player in India as well. Job Description ...
-
Regulatory Affairs SSC Team Lead
2 weeks ago
Gurgaon / Gurugram, India Michael Page Full timeOpportunity to work with a leading pharmaceutical CompanyA great role to lead a team of Regulatory Affairs AssociatesJob DescriptionThe role is a part of Global Shared Service Centre for based out of Gurugram and will be responsible for managing team of associates within Biopharma domain who will be working on enclosed below responsibilities...
-
Government Affairs
Found in: Whatjobs IN C2 - 2 weeks ago
Gurugram, India Park+ Full timePosition Overview: As the Government Affairs and Public Policy Lead, one will play a pivotal role in shaping our organization's interactions with government entities like NITI Aayog, Municipalities, Smart city officials, Police departments, Ministry of Road Transport and Highways of India by managing the relations and getting closures for smart parking...
-
Government Affairs
Found in: Appcast Linkedin IN C2 - 2 weeks ago
Gurugram, India Park+ Full timePosition Overview:As the Government Affairs and Public Policy Lead, one will play a pivotal role in shaping our organization's interactions with government entities like NITI Aayog, Municipalities, Smart city officials, Police departments, Ministry of Road Transport and Highways of India by managing the relations and getting closures for smart parking...
-
Government Affairs
Found in: Talent IN 2A C2 - 2 weeks ago
Gurugram, India Park+ Full timePosition Overview:As the Government Affairs and Public Policy Lead, one will play a pivotal role in shaping our organization's interactions with government entities like NITI Aayog, Municipalities, Smart city officials, Police departments, Ministry of Road Transport and Highways of India by managing the relations and getting closures for smart parking...
-
Park+ - Government Affairs & Public Policy Lead
Found in: Talent IN 2A C2 - 2 weeks ago
Gurugram, India Park+ Full timePosition Overview: As the Government Affairs and Public Policy Lead, one will play a pivotal role in shaping our organization's interactions with government entities and driving our public policy initiatives. One will be responsible for developing and implementing strategies to engage with policymakers, advocating for our interests, and influencing...
-
Agrim Wholesale
Found in: Talent IN 2A C2 - 2 weeks ago
Gurugram, India Agritech Full timeAgrim Wholesale - Regulatory Affairs and Compliance ManagerWe at AGRIM are seeking a highly skilled and knowledgeable Compliance Manager to join our organization. The Compliance Manager will be responsible for managing license requirements from the government, tracking developments in rules and regulations, and ensuring the validity of licenses across all...
-
Lead - Medical Affairs - Gurgaon and Bangalore
Found in: Talent IN C2 - 2 weeks ago
Gurugram, India Careerconnects Full timeJob Title: Lead MedicalAffairsLocation:Gurgaon India andBangaloreExperience:2 to 3 years in medical affairs with ahospitalAboutUs:Our client is a cuttingedgehealthcare technology startup committed to revolutionizing thehealthcare industry by leveraging innovative technologies toimprove patient care andoutcomes.RoleOverview:We are seeking amotivated and...
-
Head - Global Regulatory (Agrochemical)
Found in: Talent IN C2 - 2 weeks ago
Gurugram, India Om Sai Global HR Service Full timeJob OverviewFull-time position based in Gurgaon, responsible for leading the global regulatory activities of our agrochemical products. The ideal candidate will have extensive experience in regulatory affairs and a strong understanding of global regulatory requirements in the agrochemical industry.Roles and ResponsibilitiesLead and manage the global...