Regulatory Affairs Professional
3 months ago
Job 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 existing license as required.
Perform post market surveillance compliance & reporting for the registered devices.
To evaluate, apply & get the Product Change Notifications approved for registered devices.
Coordinate with CS & logistics team to get the Field Safety Corrective Actions implemented for devices.
Support buss. partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to fulfill regulatory requirements related to IVD devices and Medical devices.
Perform Quality system audits of suppliers, service agencies and business partners.
Maintain documentation related to all above topics including progress & record trackers.
Keep abreast on updates/ changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.
Qualification and Experience
BPharm/ M Pharm/ BSC/ MSc with 6 - 8 yrs years’ experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO) & state FDA for IVD and medical devices. Should have knowledge about IVD devices & Medical device regulations in EU & USA, Bangladesh, Sri Lanka. Good communication & interpersonal skills.
-
IPL Biologicals
2 months ago
Gurugram, India IPL Biologicals Limited Full timeIPL Biologicals is currently seeking a highly skilled and experienced Sr. Manager/Manager Regulatory Affairs to join our team. This critical role will be responsible for ensuring compliance with all applicable regulatory requirements for our biological products. The successful candidate will have a strong understanding of regulatory guidelines and...
-
Associate - Regulatory Affairs
5 months ago
Gurugram, Haryana, India DDReg Pharma Full time-Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...
-
Medical Affairs Professional
6 months ago
Gurugram, India Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Job summary The MAP is a therapeutically aligned Clinical Scientist who plays a key role within the Medical Affairs organization. The primary focus of this role is to use the individual’s knowledge of specific disease states, available treatments and...
-
Regulatory Affairs Specialist II
4 weeks ago
Gurugram, India Hollister Incorporated Full timeRegulatory Affairs function and systems. 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 globally. This involves regular high-level...
-
Dra Executive
5 months ago
Gurugram, Haryana, India YRHRS Full time**Senior DRA Executive (Regulatory Affairs)** Ø Preparation and reviewing of administrative documents. Ø Preparation and Review of Dossier in CTD,ACTD and ECTD Format. Ø Preparing the SPC and SMPC as per country guidelines. Ø Preparation of Dossier for CIS, Africa countries, Gulf Countries, and south India countries. Ø Review and Making of...
-
Medical Affairs Professional
5 months ago
Gurugram, Haryana, India Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Deputy Manager-Government Affairs
4 weeks ago
gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities:Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities.Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
R&D and Regulatory Manager
6 months ago
Gurugram, India Glanbia Full timeThe Opportunity We are seeking a passionate and innovative Manager of NPD and Regulatory Affairs, to lead the development of new health supplement products for the Indian market. You will be responsible for the entire product development lifecycle, from market research and concept generation to product launch and post-launch monitoring. This exciting role...
-
Regulatory affairs Officer
3 weeks ago
Gurugram, India Coral Drugs. Pvt. Ltd. Full timePreparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets. Submission of technical data package and Applicants Part for semi-regulated markets Submission of response to deficiencies received from authorities and customers Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments...
-
Medical Affairs Professional
1 month ago
Gurugram, Haryana, India Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Deputy Manager-Government Affairs
1 month ago
gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities: Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities. Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Deputy Manager-Government Affairs
1 month ago
Gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities:Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities.Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Deputy Manager-Government Affairs
1 month ago
Gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities: Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities. Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Deputy Manager-Government Affairs
1 month ago
gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities:Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities.Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Deputy Manager-Government Affairs
1 month ago
Gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities:Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities.Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Deputy Manager-Government Affairs
3 weeks ago
gurugram, India Olympus Medical Systems India Pvt Ltd Full timeRoles & Responsibilities: Relationship -building and maintained with key decision makers/agencies at the National/State level to develop support for company’s positions and priorities. Provide the insights on the Government upcoming and latest Policies& regulations and proactively suggest the changes anticipated so that organization adapts as per the Local...
-
Advisor, External Affairs
5 days ago
Gurugram, India Rio Tinto Full timeAbout the role Finding better ways to provide the materials the world needs. The External Affairs (EA) team has accountability for engaging external stakeholders to positively shape Rio Tinto’s policy and regulatory environment, enhance our competitive position and build trusted partnerships in our priority markets around the world. With teams and country...
-
Pristyn Care
2 days ago
Gurugram, India Pristyncare Full timeJob Title: SM /AGM-PR and Public AffairsLocation: GurgaonExperience: Minimum 7 to 12 years of experienceJob Summary:Pristyn Care is looking for a Senior Manager/Associate General Manager in PR and Public Affairs to oversee our communications strategy, drive brand reputation, and enhance relationships with key stakeholders. This role requires a seasoned...
-
Sr Mgr, Govt Affairs
5 months ago
Gurugram, India Baxter Full timeVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Regulatory Affairs
5 months ago
Gurugram, Haryana, India Ethics Group Of Companies Full time**Responsibilities**: - **Regulatory Compliance**: - Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements. - Ensure the organization's adherence to all applicable government regulations and standards. - **Drug License Application**: - Coordinate with regulatory authorities for timely approvals and compliance...