Regulatory Affairs Associate
3 days ago
Stryker is a global leader in medical technologies, driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes.
As a Regulatory Affairs Associate at Stryker, you will be responsible for Complaint Handling Review of Complaints as received from various sources. You will report complaints in Stryker's standard System followed by end-to-end closure. Your tasks include Coordinating with Division and Service for product returns/investigation and closure of received complaints, Preparing and maintenance of Complaint/SAE trackers, Evaluation of complaints for reporting to CDSCO/MvPI, Responding to Hold, Recalls initiated by Division and timely evaluation and reporting to local authorities in India, Preparation of MDSAE form for IPC and CDSCO, Maintaining Label Master for Imported product & periodic review and updates of applicable SOP and Work instructions & responding to internal/external audits.
The ideal candidate will have a BS in Engineering, Science, or related degree; or MS in Regulatory Science, with 6-10 yrs experience in RA & quality. Responsibilities also include preparing and updating checklist of documentation required for New Product Registration/License Retention/Market Standing Certificates/Non-Conviction certificates/Test Licenses etc., Reviewing of technical Dossiers as per IMDR 2017, Preparing and drafting the DMF and PMF for registrations of all classes as per IMDR 2017, Preparing checklist of PAC as per IMDR 2017.
-
Regulatory Affairs Associate
4 weeks ago
Gurgaon, Haryana, India Johnson & Johnson Full timeJOB POSITION SUMMARYThe executive regulatory affairs have the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment Assists with Document Management Archival preparation and management of Local Label Artwork along side the registration of products as per the business plan Manage the data...
-
Specialist Regulatory Affairs
3 weeks ago
Gurgaon, Haryana, India Lifelancer Full timeJob Title: Specialist Regulatory Affairs Job Location: Gurugram, Haryana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences,...
-
Regulatory Affairs Lead
3 weeks ago
Gurgaon, Haryana, India Michael Page Full timeOpportunity to lead the regulatory affairs function for India, & Africa Opportunity to work with senior leadership from multiple geographies About Our Client The client is one of the leading global medical devices player and has operations in multiple countries around the globe. They operate extensively in the Radiation, Oncology and Neurosurgery...
-
Regulatory Affairs Specialist
2 weeks ago
Gurgaon, Haryana, India Lifelancer Full timeJob Title: Regulatory Affairs Specialist Job Location: Gurugram, Haryana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Associate Job DescriptionJob title: Regulatory Affairs Specialist Your role:Regulatory Affairs Specialist – ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs...
-
Regulatory Affairs Specialist
2 days ago
Gurgaon, Haryana, India Stryker Full timeJob OverviewThe Regulatory Affairs Specialist will be responsible for driving government affairs and market access initiatives in India, supporting Stryker's brand growth while navigating social, political, and economic issues. This role will also lead BIS project initiatives to ensure compliance with applicable standards.
-
Regulatory Affairs Coordinator
5 hours ago
Gurgaon, Haryana, India Axalta Full timeAxalta is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs function, you will play a critical role in ensuring compliance with global substance management requirements and other applicable regulations.ResponsibilitiesComplete work as assigned to fulfill PSRC customer requests in a timely...
-
Director - Regulatory Affairs
3 weeks ago
Gurgaon, Haryana, India Vehere Full timeDirector - Regulatory Affairs About the job:Job Summary:- The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets.- This role will involve managing regulatory submissions, advocating compliance standards, collaborating...
-
Director - Regulatory Affairs
2 weeks ago
Gurgaon, Haryana, India Vehere Full timeDirector - Regulatory Affairs About the job:Job Summary:- The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets.- This role will involve managing regulatory submissions, advocating compliance standards, collaborating...
-
Regulatory Affairs Specialist
7 days ago
Gurgaon, Haryana, India Google Full timeAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory requirements and experience in managing external relationships with regulatory bodies and law enforcement agencies.As a key member of our team, you will be responsible for ensuring that Google's...
-
Regulatory Affairs Manager
3 weeks ago
Gurgaon, Haryana, India Takeda Full timeBy clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and I further attest that all information I submit in my employment application is true to the best of my knowledge OBJECTIVES PURPOSETo lead and develop...
-
Regulatory Affairs Specialist
4 days ago
Gurgaon, Haryana, India American Express Full timeAmerican Express is dedicated to creating a culture that values diversity, equity, and inclusion. As a Regulatory Affairs Specialist, you'll be part of a global team that's passionate about delivering exceptional customer experiences while upholding the highest standards of compliance and risk management.About the Role:Job Summary: Develop and maintain an...
-
Regulatory affairs Officer
2 weeks ago
Gurgaon, Haryana, India Lifelancer Full timeJob Title: Regulatory affairs Officer Job Location: Gurugram, Haryana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Executive Skills:DMF, ICH, DRUG MASTER FILE, API, Preparation of LOA, Use of eCTD software's,Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated...
-
Global Regulatory Lead
1 week ago
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeThe Associate Director Director Global Regulatory Leader Global Regulatory Affairs GRA Specialty Business Brands and Innovative Medicines partners with leaders across the organization to be the face of the asset from a regulatory perspective The role will be responsible for formulating developing and executing a comprehensive regulatory...
-
Public Affairs Strategist
2 days ago
Gurgaon, Haryana, India Michael Page Full timeOur MissionWe are a Global Public Affairs and Communications firm dedicated to delivering exceptional results for our clients. We are currently seeking an experienced professional to join our team as a Senior Manager.Key ResponsibilitiesDevelop and implement effective public affairs strategies to support clients' goals and objectivesIdentify and mitigate...
-
Regulatory Associate/Sr Regulatory Associate
2 days ago
Gurgaon, Haryana, India inVentiv Health Clinical SRE, LLC Full timeJob DescriptionDescriptionRegulatory Associate/Sr Regulatory AssociateSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the...
-
VP - Public Affairs
3 weeks ago
Gurgaon, Haryana, India Michael Page Full timeopportunity to work with the leadership Career growth About Our Client Global Public Affairs firm Job Description Develop and execute public affairs strategies for clients in the logistics and infrastructure sectors. Provide strategic counsel to clients on public policy, regulatory issues, and stakeholder engagement. Build and maintain...
-
Regulatory Affairs Specialist
4 hours ago
Gurgaon, Haryana, India inVentiv Health Clinical SRE, LLC Full timeCompany OverviewSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
-
Public Affairs Manager
3 weeks ago
Gurgaon, Haryana, India Weber Shandwick Full timeAs a Manager – Public Affairs, you will play a key role in advising clients on government relations, policy communications and advocacy, and regulatory affairs. You will be responsible for developing strategic engagement plans, building relationships with key stakeholders, delivering strategic client-ready content and executing high-impact public affairs...
-
Public Affairs Manager
3 weeks ago
Gurgaon, Haryana, India Weber Shandwick Full timeAs a Manager – Public Affairs, you will play a key role in advising clients on government relations, policy communications and advocacy, and regulatory affairs. You will be responsible for developing strategic engagement plans, building relationships with key stakeholders, delivering strategic client-ready content and executing high-impact public affairs...
-
R&D and Regulatory Manager
2 weeks ago
Gurgaon, Haryana, 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...