1,879 Regulatory Affairs Manager jobs in India

Regulatory Affairs Manager

Bangalore, Karnataka ThermoFisher Scientific

Posted 5 days ago

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Job Description

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Regulatory affairs manager

Mumbai, Maharashtra SOZIO

Posted today

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Job Description

Company :


Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.

The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.

With the integration of Synarome in 2021, Sozio ties back to its legacy by returning to its initial activity : raw materials. This acquisition enhances Sozio perfumers’ palette of premium ingredients – both synthetic and natural – and iconic specialties such as Ambrarome and Animalis.

With these generations of learning and knowledge, an expertise in natural fragrances and an international presence, Sozio has become a key player in the perfumery landscape.


Summary:


Under limited supervision, evaluates formulations to comply with industry country specific, federal, state, local shipping and customer guidelines in Asia and India.



We recruit a Regulatory affairs manager



Role & Responsibilities


Under the direction of the Regulatory Director, the regulatory manager will:

  • Review formulations to ensure compliance with industry and customer guidelines.
  • Request product information from suppliers as needed to satisfy customer fragrance needs within department guidelines.
  • Maintain master files for Material Safety Data Sheets for raw materials and other vendor information.
  • Process regulatory technical correspondence for sales and customers, and maintains master files on submissions.
  • Perform other duties as time and customers dictate.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Other duties may be assigned.


Education

  • High school Diploma or equivalent.


Professional Experience

  • 5 years of work experience in a related field.


Skills & Competencies

  • Reliable and punctual attendance required.
  • Regulatory knowledge.
  • Computer knowledge and able to operate a computer.
  • Understand complex regulations and basics in chemistry.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Bengaluru, Karnataka beBeeCompliance

Posted today

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Job Description

About this Compliance Role:

We are seeking a skilled professional to support our regulatory requirements in India and international countries.

Key responsibilities include applying for and renewing licenses and certifications, arranging phytosanitary inspections, and coordinating with laboratories and quarantine officers.

Additionally, you will provide guidance on country-specific product classification, maintain a compliance tracker for each product and destination country, and ensure smooth coordination with government departments and testing labs.

What We Are Looking For:

To be successful in this role, you will need 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance. You should also have a strong understanding of regulatory filings for African/CIS countries.

Able to work remotely and independently while managing communication with labs, certification bodies, and government departments, you will possess excellent organizational and documentation skills.

A Great Opportunity:

This role offers a chance to make a significant impact on our compliance efforts and work with a dynamic team.

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Erode, Tamil Nadu beBeeCompliance

Posted today

Job Viewed

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Job Description

Job Overview

We are seeking a specialist to support our compliance requirements in India and international destination countries. This role is ideal for professionals with experience in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.

Key Responsibilities:

  • Apply for and renew licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS as required.
  • Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
  • Provide guidance on country-specific product classification (e.g., cosmetic vs. medicine).
  • Maintain a compliance tracker for each product and destination country.
  • Ensure smooth coordination with government departments, regulatory authorities, and testing labs.

Requirements:

  • 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance.
  • Strong understanding of regulatory filings for African/CIS countries (preferred).
  • Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
  • Excellent organizational and documentation skills.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Nagpur, Maharashtra beBeeCompliance

Posted today

Job Viewed

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Job Description

About this Position:

We are seeking a dedicated Regulatory Compliance Professional to support our compliance requirements in India and international destination countries.

Key Responsibilities:

  • Obtain and renew licenses and certifications as required.
  • Coordinate phytosanitary inspections and liaise with laboratories and quarantine officers.
  • Provide guidance on country-specific product classification.
  • Maintain accurate compliance records for each product and destination country.
  • Ensure seamless coordination with government departments, regulatory authorities, and testing labs.

Requirements:

  • Minimum 3–6 years of experience in regulatory affairs.
  • Strong understanding of regulatory filings for African/CIS countries.
  • Able to work independently and remotely.
  • Excellent organizational and documentation skills.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Manager

Thoothukudi, Tamil Nadu beBeeCompliance

Posted today

Job Viewed

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Job Description

About this Opportunity:

We are seeking an experienced Regulatory Compliance Specialist to support our compliance needs in India and international markets. This role is ideal for professionals with expertise in handling regulatory filings, certifications, and export-related compliance in the pharmaceutical, Ayurveda, nutraceuticals, or cosmetics industries.

Key Responsibilities:

  • Obtain and maintain licenses and certifications as required.
  • Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
  • Provide guidance on product classification for each country.
  • Maintain a compliance tracker for each product and destination country.
  • Ensure smooth coordination with government departments, regulatory authorities, and testing labs.

Requirements:

  • A minimum of 3–6 years of experience in regulatory affairs, preferably in the pharmaceutical, Ayurveda, or export compliance sectors.
  • Strong understanding of regulatory filings for African/CIS countries (preferred).
  • Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
  • Excellent organizational and documentation skills.

To succeed in this role, you should possess strong organizational skills and be able to manage multiple tasks simultaneously. Additionally, excellent communication and interpersonal skills are essential for effective collaboration with cross-functional teams.

This advertiser has chosen not to accept applicants from your region.

Regulatory affairs manager

Mumbai, Maharashtra SOZIO

Posted today

Job Viewed

Tap Again To Close

Job Description

Company :


Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.

The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.

With the integration of Synarome in 2021, Sozio ties back to its legacy by returning to its initial activity : raw materials. This acquisition enhances Sozio perfumers' palette of premium ingredients - both synthetic and natural - and iconic specialties such as Ambrarome and Animalis.

With these generations of learning and knowledge, an expertise in natural fragrances and an international presence, Sozio has become a key player in the perfumery landscape.


Summary:


Under limited supervision, evaluates formulations to comply with industry country specific, federal, state, local shipping and customer guidelines in Asia and India.



We recruit a Regulatory affairs manager



Role & Responsibilities


Under the direction of the Regulatory Director, the regulatory manager will:

  • Review formulations to ensure compliance with industry and customer guidelines.
  • Request product information from suppliers as needed to satisfy customer fragrance needs within department guidelines.
  • Maintain master files for Material Safety Data Sheets for raw materials and other vendor information.
  • Process regulatory technical correspondence for sales and customers, and maintains master files on submissions.
  • Perform other duties as time and customers dictate.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Other duties may be assigned.


Education

  • High school Diploma or equivalent.


Professional Experience

  • 5 years of work experience in a related field.


Skills & Competencies

  • Reliable and punctual attendance required.
  • Regulatory knowledge.
  • Computer knowledge and able to operate a computer.
  • Understand complex regulations and basics in chemistry.
This advertiser has chosen not to accept applicants from your region.
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Regulatory affairs manager

Mumbai, Maharashtra SOZIO

Posted today

Job Viewed

Tap Again To Close

Job Description

Company :

Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.

The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.

With the integration of Synarome in 2021, Sozio ties back to its legacy by returning to its initial activity : raw materials. This acquisition enhances Sozio perfumers’ palette of premium ingredients – both synthetic and natural – and iconic specialties such as Ambrarome and Animalis.

With these generations of learning and knowledge, an expertise in natural fragrances and an international presence, Sozio has become a key player in the perfumery landscape.

Summary:

Under limited supervision, evaluates formulations to comply with industry country specific, federal, state, local shipping and customer guidelines in Asia and India.

We recruit a Regulatory affairs manager

Role & Responsibilities

Under the direction of the Regulatory Director, the regulatory manager will:

- Review formulations to ensure compliance with industry and customer guidelines.
- Request product information from suppliers as needed to satisfy customer fragrance needs within department guidelines.
- Maintain master files for Material Safety Data Sheets for raw materials and other vendor information.
- Process regulatory technical correspondence for sales and customers, and maintains master files on submissions.
- Perform other duties as time and customers dictate.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Other duties may be assigned.

Education

- High school Diploma or equivalent.

Professional Experience

- 5 years of work experience in a related field.

Skills & Competencies

- Reliable and punctual attendance required.
- Regulatory knowledge.
- Computer knowledge and able to operate a computer.
- Understand complex regulations and basics in chemistry.
This advertiser has chosen not to accept applicants from your region.
 

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