936 Regulatory Affairs Professional jobs in India

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team.

Key Responsibilities

Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada.

Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews.

Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content.

Conduct regulatory impact assessments for design changes.

Qualifications

Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field.

Minimum of 3 years of regulatory experience in medical device industry.

Proven experience contributing to regulatory filings.

Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada.

Ability to interpret and apply regulatory requirements to complex technical issues.

Excellent communication, organization, and problem-solving skills.

Experience in supporting responses to regulatory agencies.

Ability to work independently and collaboratively in a cross-functional team environment.

Preferences

Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements.

Proven experience in contributing to international regulatory submissions.

RAC (Regulatory Affairs Certification) or simliar professional certification

Internal Auditor Training

Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with Organization policy and procedures

Accountable to the functional CTA Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project

Accountability for agreed tasks and projects

Ensure independent communication, with a range of internal Organization staff, in support achievement of the assigned goals

Ensure compliance with Organization CTA process through timely action and completion of records in internal Organization systems

Ensure quality of own work to agreed timeframes, including compliance with Organization systems and record keeping

A good understanding of Clinical Trial Regulation (and Directive), DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types

Key Responsibilities ?:
Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
Provide support to global and local GRA team members through preparation of other labelling documents as required
Complete quality and consistency checks of labelling document content.
Efficiently coordinate and manage labelling documentation and data in regulatory systems.
Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.
For some roles, may be required to perform translation of labelling text into identified languages.
May become a Subject Matter Expert in country/regional labelling content and process.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Position Summary

The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below

• Develop and implement regulatory strategies for biosimilar products in LATAM.

• Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.

• Ensure adherence to regional regulatory reuqirements

• Evaluate and implement regulatory changes impacting product lifecycle.

• Manage post-approval activities including labeling updates, renewals, and change control assessments.

• Ensure compliance with regional regulations and company SOPs.

• Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.

• Liaise with local health authorities, business partners, and internal teams (CMC, QA, PV, Medical Affairs).

• Support agency meeting preparations and GMP certification processes.

• Assess regulatory impact of manufacturing and quality changes.

• Define submission plans and timelines for change control activities.

• Hands-on experience with biosimilars submission.

Experience:

Minimum 4 years in Regulatory Affairs within the pharmaceutical/biotech industry