1,550 Regulatory Affairs Specialists jobs in India

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

Job Title: Regulatory Affairs Junior Manager

Location: At Ahmedabad Office , Near Thaltej Crossroads

Department: RA

Reports To: RA Head and Regulatory Department at HO /Director

Employment Type: Full Time

Office hours : 9,30 AM to 6 PM

Week of: Sunday and Saturday Half Day

Preferred Gender : M/F

Experience : Minimum 2 years

Job Summary:

We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.

Key Responsibilities:

• Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
• Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
• Support product development teams with regulatory input during the design and development phases.
• Conduct regulatory impact assessments for design or process changes.
• Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
• Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
• Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
• Assist in internal audits and inspections, including document preparation and response coordination.
• Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
• Participate in risk management, clinical evaluation, and post-market surveillance activities.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
• Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
• Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
• Strong analytical, organizational, and communication skills.
• Attention to detail and ability to work independently as well as in a team environment.

Preferred Qualifications:

• Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Experience interacting with regulatory bodies or notified bodies.
• Familiarity with eCTD or electronic submission platforms.

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.

Job Title: Regulatory Affairs Junior Manager

Location: At Ahmedabad Office , Near Thaltej Crossroads

Department: RA

Reports To: RA Head and Regulatory Department at HO /Director

Employment Type: Full Time

Office hours : 9,30 AM to 6 PM

Week of: Sunday and Saturday Half Day

Preferred Gender : M/F

Experience: Minimum 2 years

Job Summary:

We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices. The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.

Key Responsibilities:

• Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
• Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
• Support product development teams with regulatory input during the design and development phases.
• Conduct regulatory impact assessments for design or process changes.
• Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
• Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
• Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
• Assist in internal audits and inspections, including document preparation and response coordination.
• Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
• Participate in risk management, clinical evaluation, and post-market surveillance activities.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices.
• Knowledge of medical device regulations such as EU MDR, US FDA 21 CFR Part 820, ISO 13485, and CDSCO requirements.
• Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
• Strong analytical, organizational, and communication skills.
• Attention to detail and ability to work independently as well as in a team environment.

Preferred Qualifications:

• Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Experience interacting with regulatory bodies or notified bodies.
• Familiarity with eCTD or electronic submission platforms.

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

Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices. The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.Key Responsibilities:Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.Support product development teams with regulatory input during the design and development phases.Conduct regulatory impact assessments for design or process changes.Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.Assist in internal audits and inspections, including document preparation and response coordination.Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.Participate in risk management, clinical evaluation, and post-market surveillance activities.Qualifications:Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices.Knowledge of medical device regulations such as EU MDR, US FDA 21 CFR Part 820, ISO 13485, and CDSCO requirements.Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).Strong analytical, organizational, and communication skills.Attention to detail and ability to work independently as well as in a team environment.Preferred Qualifications:Certification in Regulatory Affairs (e.g., RAC) is a plus.Experience interacting with regulatory bodies or notified bodies.Familiarity with e CTD or electronic submission platforms.

• Prepare and submit regulatory filings, such as New Drug Applications (NDAs), Investigational New Drug (IND) applications, and variations, to health authorities.
• Review and approve product labeling, promotional materials, and advertising content for regulatory compliance.
• Maintain up-to-date knowledge of global and regional pharmaceutical regulations and guidelines.
• Liaise with regulatory agencies, respond to queries, and manage regulatory correspondence.
• Ensure that company procedures and practices comply with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GPvP).
• Assess the regulatory impact of product changes and implement necessary submissions.
• Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing departments to ensure regulatory requirements are met.
• Manage the lifecycle of regulatory submissions and maintain regulatory databases.
• Conduct regulatory intelligence activities to identify emerging trends and opportunities.
• Provide regulatory guidance and support to internal teams.
• Participate in regulatory audits and inspections.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
• Strong knowledge of regulatory submission processes and guidelines (e.g., FDA, EMA, CDSCO).
• Experience with dossier preparation and submission management.
• Excellent written and verbal communication skills, with strong attention to detail.
• Proficiency in regulatory information management systems.
• Ability to analyze complex scientific and technical data.
• Strong problem-solving and decision-making abilities.
• Ability to work independently and collaboratively in a team environment.
• Familiarity with pharmaceutical product development and manufacturing processes.