Executive Regulatory Affairs Labelling

3 days ago

Mumbai Maharashtra, India Piramal Pharma Solutions Full time

Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla
Travel: Low:
**JOB OVERVIEW**:
Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. Participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations

**KEY STAKEHOLDERS: INTERNAL**

Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team

**KEY STAKEHOLDERS: EXTERNAL**

Country Distributors, Health Authority (HA), CMOs and external partners

**REPORTING STRUCTURE**: (Reports To/ Direct Reports Y/N)
- Manager - Labelling

**RELEVANT EXPERIENCE**:
1-2 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred).

**KEY ROLE & RESPONSIBILITIES**
- Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions
- Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region.
- Coordinating with the different stakeholders for timely labeling related submission/approval and query solving.
- Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling
- Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA
- Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs
- Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates
- Contribute to the development and/or review of all labeling aspects included in Promotional Material.
- Development and maintenance of a central repository for all labeling components

**KEY COMPETENCIES**:

- Must have solid interpersonal and organization skills for interfacing with others.
- Knowledge of Health Authority labeling regulations and requirements.
- Self-directed, motivated, organized, flexible and accountable.
- Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment.
- Project management skills is a plus

  • Regulatory Affairs Labeling Executives

    2 weeks ago

    Mumbai, Maharashtra, India G&L Healthcare Advisors Full time

    Contract: Permanent Full-Time Closing Date: 18/07/25 We are seeking experienced Regulatory Affairs Labeling professionals to join our global regulatory team. In this role, you will be working in a matrix team of global consultants, with responsibilities for one or more of G&L’s clients. You would be responsible for ensuring accurate and compliant...

  • Executive Regulatory Affairs Labelling

    3 days ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low: **JOB OVERVIEW**: Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and...

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...

  • Executive- Labelling, Regulatory Affairs

    5 days ago

    Mumbai, Maharashtra, India Apotex Research Private Limited Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

  • Regulatory Affairs Officer

    1 week ago

    Santacruz West, Mumbai, Maharashtra, India Globofarm International Pvt Ltd Full time

    Job Profile - Regulatory Affairs (FSSAI) Position Regulatory Affairs - FSSAI Compliance Location Santacruz West mumbai Reports To Head - Director Role Purpose To ensure that all nutraceutical, pharmaceutical ingredients, oils, botanicals, and food products marketed/imported/distributed by the company are fully compliant with FSSAI regulations and other...

  • Trainee- Labelling, Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Apotex Research Private Limited Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

  • Regulatory Affairs Executive

    1 week ago

    Mumbai, Maharashtra, India IMPACT LABS PRIVATE LIMITED Full time

    **Licensing & Approvals**: - Obtain product permissions from relevant regulatory authorities. - Liaise with government agencies to ensure timely approvals and renewals **Dossier Compilation**: - Compile, review, and submit regulatory dossiers in **CTD (Common Technical Document)** and **ACTD (ASEAN Common Technical Document)** formats. - Ensure...

  • Trainee, Regulatory Affairs Labeling

    5 days ago

    Mumbai, Maharashtra, India Apotex Inc. Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

  • Regulatory Affairs Executive

    1 week ago

    Khopat, Thane, Maharashtra, India Generic Aadhaar Full time

    **JOB DESCRIPTION OF REGULATORY AFFAIRS** **TOTAL YEARS OF EXPERIENCE**: 2-4 YEARS - Handling dossier, COPP submission and query Handling for South East Asian Country, East Africa, Latin America, Central America, Europe. - In depth knowledge about regulatory requirements for above region - Need to work independently - Need to have knowledge about legal...