109 Financial Regulations jobs in Mumbai

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).

Location: Andheri, Mumbai.

Qualification: M. Pharm. (Experienced preferred).

Experience- 1-5 Years

JOB DESCRIPTION – Regulatory Affairs (Domestic)

The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with

experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing):

· Prepare registration dossier for procuring certificates/license from local FDA, DCGI and

· FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs

· & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.

· Confirm product formula and label acceptability, as well as the receipt of necessary licenses,

· prior to the release of product.

· Co-ordinate with QC and R&D departments for technical documents (manufacturing

· documents like batch records, specifications, analytical methods, validation reports, and

· stability data) required to be incorporated in the registration dossiers.

· Ensure timely renewal of drug and food licenses maintained by head office and also branch

· offices based at various states in the country.

· Online application for obtaining test license for import purpose.

· Maintain archival of all regulatory permissions.

· Keep abreast of the updates pertaining to regulatory requirements and accordingly

· implement them.

· Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules:

· Formulate and implement statutory requirements pertaining to the artworks of the

· products (label, carton, package insert, patient information leaflet, etc.).

· Review the artwork of all packaging material.

· Prepare package insert as per New Drugs and Clinical Trials Rules 2019.

· Pharmacovigilance

· Provide high quality medical writing from planning and coordination of literature research.

· Draft and review PSURs with focus on medical aspects of the products and safety sections.

· Review of Risk Management Plans as per Regulatory requirement.

· Good knowledge in assessing the risk-benefit of a product and identify any gaps in the

· aggregate documents.

· Perform scientific review of aggregate reports / ICSRs produced by PV Associates.

Hi Everyone,

I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.

Please refer below JD and share your profile on

• Experienced in preparing, review and compile regulatory submissions.
• Maintain compliance with US FDA and ICH requirements.
• Should have experienced in pre-submission activity.
• Experienced in CMC.
• Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.
• Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
• Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
• Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
• Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
• Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
• Review and approve change controls from global manufacturing partners to assess regulatory impact.
• Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.

Thank you!

Relocation Assistance Offered Within Country

Job Number # Mumbai, Maharashtra, India

Who We Are

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name

Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.

Brief introduction - Role Summary/Purpose :

• This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.

Responsibilities:

• Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
• Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
• Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
• Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
• Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
• Update and maintain product registration and ingredients archives, databases and tracking tools.
• Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
• Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
• Manage the distribution lists of SOP and the archiving in the documentation system.

Artwork Approval:

• Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
• Assist the Regional Regulatory Affairs managers with artwork review and approval

Regulatory intelligence and product advocacy activities:

• Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
• Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
• Track Competent Authority websites and databases for news related to new product registrations.
• Assist Regional Regulatory team to deliver and manage Regulatory Assessment

Required Qualifications :

• BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
• Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
• Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
• Knowledge of industry practices, techniques and standards.
• Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.

Preferred Qualifications:

• Good written and verbal communicator with excellent interpersonal skills.
• Good planning and organizing skills.

• Ability to work under stress and meet deadlines.

• Fluency in spoken and written English is mandatory.

• Fluency in languages is advantageous.

Our Commitment to Inclusion

Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.

Equal Opportunity Employer

Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.

We're Hiring: Regulatory Affairs – CMC Associate

Location: Navi Mumbai

Years of Experience:4+ years

Work from Office

Notice Period: Looking for immediate joiners

Skills Required:

Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.

4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting.

Strong understanding of US FDA regulations and ICH guidelines.

Experience in handling pre- and post-approval submissions is required

Interested candidates can share their resumes on

Key Roles and Responsibilities:

Regulatory Compliance & Licensing:

• Lead and manage all regulatory approvals, licensing, and registration activities across relevant regulatory authorities to ensure timely approvals (FSSAI, Tea Board of India, MSME, Factory License, Trade License, etc.).
• Develop and oversee robust systems for regulatory compliance reporting (e.g., Whistleblower avenues).
• Establish and implement compliance frameworks aligned with food safety and regulatory guidelines.
• Provide proactive strategic advice on regulatory matters across domains including Health, Safety, Environment, Food Safety, Pollution Control, Customs, and Product Liability.
• Ensure up-to-date renewals and compliance for all essential business licenses across group companies and associates.
• Ensure full compliance with FSSAI and Legal Metrology standards across all products and packaging.
• Continuously monitor, interpret, and implement changes to food regulations (especially FSSAI updates).

Stakeholder Management & Coordination:

• Establish and manage an effective stakeholder engagement matrix with central/state authorities.
• Liaise with regulatory bodies, consultants, and local agencies for licensing processes, issue resolution, and standard implementation.
• Maintain all necessary documentation and ensure readiness for regulatory review or inspections.

Quality Control & Food Safety:

• Coordinate with QC teams to ensure internal and external product testing complies with FSSR and other regulatory standards.
• Lead regulatory and food safety activities for India and international markets to ensure product compliance.
• Drive the resolution of product safety issues and customer complaints through testing, analysis, and action.

Product Labelling & Trademark Compliance:

• Validate and ensure accuracy of product labelling for compliance with Indian and international regulations (e.g., USFDA, EU).
• Collaborate with marketing and design teams for creation and approval of compliant labels and packaging artwork.
• Maintain and manage barcode databases and ensure labelling readiness for retail and export.
• Coordinate with external agencies for application, renewal, and protection of trademarks. Review legal drafts for oppositions/counter-statements and provide required documentation.

Regulatory Audits:

• Develop internal control systems and monitor adherence through regular and surprise audits at plant, warehouse, and store levels.
• Create and execute quarterly/half-yearly audit plans; lead both internal and external audit activities.
• Identify process gaps and risks, present findings to management, and drive corrective actions.
• Maintain weekly/monthly compliance trackers and provide updates to senior leadership.
• Collaborate with HODs and external auditors to ensure full statutory, regulatory, and client compliance.

Required Skills & Qualifications:

• Bachelor's Degree
  in
  Nutrition, Food Science, or Nutraceuticals
  (Mandatory)
• Master's Degree
  in
  Nutraceuticals
  (Preferred)
• In-depth knowledge of
  Nutraceutical NPD
  , regulatory affairs, FSSAI, Legal Metrology, and international food regulations.