Current jobs related to Regulatory Affairs - India - Michael Page


  • India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej CrossroadsDepartment:RAReports To:RA Head and Regulatory Department at HO /DirectorEmployment Type:Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday andSaturday Half DayPreferred Gender: M/FExperience : Minimum 2 yearsJob Summary:We are seeking a proactive and...


  • India Frisch Medical Devices PVT LTD Full time

    Job Title:Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office, Near Thaltej CrossroadsDepartment:RAReports To:RA Head and Regulatory Department at HO /DirectorEmployment Type:Full TimeOffice hours :9,30 AM to 6 PMWeek of:Sunday and Saturday Half DayPreferred Gender:M/FExperience:Minimum 2 yearsJob Summary:We are seeking a proactive and...


  • India beBeeRegulatoryAffairsSpecialist Full time

    Job Overview: As a skilled Regulatory Intelligence Specialist, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry. You will support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities.">This is...


  • India - Andra Pradesh - Hyderabad beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Title: Regulatory Affairs CMC AssociateWe're seeking a highly skilled and experienced Regulatory Affairs professional to join our team. As a Regulatory Affairs CMC Associate, you will play a key role in ensuring the quality and regulatory compliance of our products.Responsibilities:Preparation of CMC sections of new registration files, TMACs, briefing...


  • India Ipca Laboratories Limited Full time

    Position: Executive - Regulatory affairs formulation for USA market.Qualification: B.Pharm/M.PharmExperience: 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:Preparation of registration dossiers as per the US Regulatory guidelinesPreparation of renewal application as per...


  • India, Gurgaon, beBeeRegulatoryAffairs Full time

    Maersk is seeking a seasoned professional to support business growth in India by navigating public policy and regulatory environments.About the RoleThis role involves working closely with senior leaders to develop strategies that drive business objectives while mitigating risks associated with changing regulations and policies.Business Development and Issues...


  • hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Senior Regulatory Affairs Associate ( Biologics )4 to 8 years of experience of authoring, compiling and submission of...


  • hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Senior Regulatory Affairs Associate ( Biologics ) 4 to 8 years of experience of authoring, compiling and...


  • India Sol-Millennium Medical Group Full time

    Job Description : We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will...


  • India Sol-Millennium Medical Group Full time

    Job Description:We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve...

Regulatory Affairs

1 month ago


India Michael Page Full time
About Our Client

Our client is a global healthcare company committed to providing high-quality, affordable pharmaceuticals and healthcare solutions across emerging markets.

Job Description

- Management and coordination with Indian vendors of technical and legal requirements for getting the marketing authorization approval at the Health Authorities in LATAM countries.

- Pre-Audit and Audit of the dossier for new applications of products from India to be submitted in LATAM countries.

- Strong follow up with indian vendors, by email, by phone or by personal meetings in order to comply and deliver each of the technical and legal documents needed to comply regulatory plan in a timely manner.

- Coordinate regular meetings between internal RA team and Vendor´s RA team to follow-up the ongoing projects

- Coordinate with Indian vendors the shipment of samples and original hard copies of documents required for the submission in each country.

- Coordinate with Indian vendors to develop any special requirement such as transport validations, In vivo or In Vitro bioequivalences to comply with special regulation in the region

The Successful Applicant

- Proven experience in handling portfolio submissions from a regulatory affairs standpoint, including evaluation of multiple contractors

- Strong communication and collaboration skills

- Demonstrated ability to work independently with a results-driven approach

What's on Offer

The company fosters a dynamic and agile work environment where employees are encouraged to take ownership, innovate, and grow rapidly within the organization.