Executive, Regulatory Affairs
3 weeks ago
Job 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 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 Essential knowledge and skills: • Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy • Minimum 2-4 years Industry Experience in Regulatory Affairs, preferably in medical devices. Sound understanding of MD rules and regulations in India. • Experience of Submitting, Registering and maintaining Product registrations with MOH • Experience in assembling product dossiers for submission to Regulatory Authorities. • Good technical writing and communication skills. Core competencies required for this role: • Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
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Sr. Executive, Regulatory Affairs
3 weeks 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...
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Regulatory Affairs Executive
1 month 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...
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Regulatory Affairs Executive
4 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...
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Regulatory Affairs Executive
4 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...
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Regulatory Affairs SSC Team Lead(Biopharma)
3 weeks 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 ...
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Government Affairs
4 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...
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Government Affairs
4 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...
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Government Affairs
4 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...
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Head - Government Affairs
4 hours ago
gurugram, India Michael Page Full timeMeritocratic Culture Leadership Role About Our Client Our client is one of the Top Renewable companies in the Indian market. Job Description Develop and implement strategies to effectively engage with government stakeholders, including ministries, regulatory agencies, and industry associations. Monitor and analyze policy and...
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Park+ - Government Affairs & Public Policy Lead
4 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...
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Regulatory Specialist
7 days ago
Gurugram, India Hollister Full timeSummary: As an individual contributor, the function of a Regulatory Affairs Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for...
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Regulatory Specialist
7 days ago
gurugram, India Hollister Full timeSummary: As an individual contributor, the function of a Regulatory Affairs Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for...
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Antara Senior Care
6 days ago
Gurugram, India Antara Assisted Care Services Limited Full timeRole Summary:- As a Clinical Affairs Specialist for D2C Healthcare New Products at AGEasy by Antara, you will play a critical role in leading the planning, execution, and management of clinical studies and trials for our direct-to-consumer healthcare products. Your responsibilities will include developing and implementing clinical research strategies,...
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Agrim Wholesale
4 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...
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Regulatory Specialist
7 days ago
Gurugram, India Hollister Incorporated Full timeSummary:As an individual contributor, the function of a Regulatory Affairs Specialist collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for registrations...
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Lead - Medical Affairs - Gurgaon and Bangalore
4 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...
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Regulatory Affairs Professional
2 days ago
gurugram, India Siemens Healthcare Private Limited Full timeJob Responsibilities: Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017. Responsible to obtain new wholesale license of IVD devices & medical devices from state FDA, renew/amend...
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Regulatory Affairs Professional
1 hour ago
Gurugram, India Siemens Healthcare Private Limited Full timeJob Responsibilities: Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017. Responsible to obtain new wholesale license of IVD devices & medical devices from state FDA, renew/amend...
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Manager - Corporate Affairs - SCO
2 weeks ago
gurugram, India DP World Australia Full timeImplement the strategic Public Policy Advocacy plans and oversee the engagement objectives to develop and maintain productive relations with policymakers, trade associations, and identified critical stakeholders to support and further the business goals. Monitor legislative, regulatory, and policy developments impacting the logistics sector, analyze...
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Manager - Corporate Affairs - SCO
2 weeks ago
Gurugram, India DP World Australia Full timeImplement the strategic Public Policy Advocacy plans and oversee the engagement objectives to develop and maintain productive relations with policymakers, trade associations, and identified critical stakeholders to support and further the business goals. Monitor legislative, regulatory, and policy developments impacting the logistics sector, analyze...