Current jobs related to Executive- Labelling, Regulatory Affairs - Mumbai Maharashtra - Apotex Research Private Limited

  • Executive Regulatory Affairs Labelling

    4 weeks ago

    Mumbai, Maharashtra, India Piramal Pharma Solutions Full time

    Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai 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...

  • Executive Regulatory Affairs Labelling

    4 weeks ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai 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,...

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, Maharashtra, India Clini launch Business Solutions Full time

    We are seeking a knowledgeable and experienced Regulatory Affairs Specialist with expertise in the Drugs & Cosmetics Act and FSSAI regulations, as well as experience in FDA-related activities. This role is essential for ensuring robust functional and cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.) and for the transparent execution...

  • Regulatory Affairs Executive

    5 days ago

    Pune, Maharashtra, India Nissar Transformers Pvt Ltd Full time

    Position - Regulatory Affairs (RA) Executive Location - pirangut Experience - 1 to 3 yrs **Responsibilities**: Strategy & Planning: Develop regulatory strategies for product approvals. Guide project teams on regulatory needs. Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs). Ensure timely and accurate...

  • Regulatory Affairs Executive

    3 weeks ago

    Pune, 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, organising,...

  • 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 Executive

    3 weeks 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...

  • 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...

  • Regulatory Affairs Officer

    3 weeks ago

    Wagholi, Pune, Maharashtra, India Statistical Pharma Full time

    **Regulatory Affairs Officer Duties & Responsibilities** The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation,...

  • Regulatory Affairs Executive

    4 weeks ago

    Navi Mumbai, Maharashtra, India Eclipse Prism Medical Devices Pvt. Ltd. Full time

    Job Description: - Responsible for writing clinical evaluation reports. - Able to interpret, analyse and draw conclusions from the clinical data obtained from clinical trials, literature, etc. - Responsible for preparing software documentation - Responsible for preparing technical documentation for regulatory compliance (EU MDR, CDSCO) - Responsible for...

  • Executive Regulatory Affairs

    1 day ago

    mumbai, India Piramal Group Full time

    Business: Piramal Critical Care  Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low Job Overview To manage Regulatory Filings for Europe with minimum supervision.  Key Stakeholders: Internal Country manager, Plant, QA , Artwork department, Supply Chain, PV Key Stakeholders: External  Health Authorities, Distributors Reporting...

  • Manager Regulatory Affairs

    3 weeks ago

    Mumbai, India Abbott Laboratories Full time

    POSITION: Regulatory Affairs Manager Primary Function/Primary Goals/Objectives: Provide support for the regulatory department to ensure efficient and compliant business processes and environment. Execute regulatory tasks and play a consultative role by partnering across business functions. Assist in identifying data needed, obtaining these data...

  • Sr. Executive

    1 day ago

    mumbai, India Lifelancer Full time

    Job Title: Sr. Executive -Regulatory Affairs. Job Location: Mumbai, Maharashtra, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Compliance, FDA Regulations, Quality Assurance, Documentation Management, Risk Assessment, Communication Skills, Project Management, Regulatory Operations,Position:...

  • Regulatory Affairs Executive(Female)

    4 weeks ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...

  • Manager Regulatory Affairs

    1 day ago

    mumbai, India Lifelancer Full time

    Job Title: Manager Regulatory Affairs Job Location: Mumbai, Maharashtra, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate POSITION: Regulatory Affairs ManagerPrimary Function/Primary Goals/ObjectivesProvide support for the regulatory department to ensure efficient and compliant business processes and environment....

  • Regulatory Affairs Officer

    4 weeks ago

    Mumbai, India Zieva Farm Pvt Lt Full time

    Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies - Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc. - Provide expert regulatory input...

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...

  • Associate, Regulatory Affairs

    3 weeks ago

    Mumbai, Maharashtra, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country Job Number #163733 - 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...

  • Regulatory Affairs Executive

    2 weeks ago

    Vile Parle, Mumbai, Maharashtra, India Vision Enterprises Full time

    Required Regulatory Affairs Executive in Pharma Industry. Industry Background:Pharma (HO) Post: Regulatory Affairs Executive Gender: Preferably Female. Qualification : - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. **Position 4 : Regulatory Executive (preferably female)** **Eligibility**: - M. Sc / B. Sc / M. Pharm / B....

Executive- Labelling, Regulatory Affairs

1 month 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 integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
Perform for all the labelling update and maintenance activities with respect to New Product Development Label creation and Product Life Cycle maintenance update for products in Canada Market. Interact with Point of contact for product allocated to understand any data related queries or data availability issues. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork. Interact on a peer level with ARPL colleagues and Canada affiliates for addressing Health Authorities requirement or queries. Maintain all the trackers for label to ensure the timely submission of the labels to health authority.

**Responsibilities**:

- Responsible for coordination & preparation of regulatory submissions and strategies.
- Prepare and submit all the supporting documents for labelling submissions as per the type of submission for Canada Market.
- Co-ordinate with POC/ Vendor for Artwork creation and update.
- Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.)
- Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada market.
- Develop & maintain regulatory knowledge of Canada regulations.
- Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product approvals.
- Perform ESG submissions and maintain the acknowledgments.
- Author the responses and be a decision maker for the changes applicability in the labels
- Define the priority of the labelling requirements and plan the submission based on priority.
- Maintains user-level knowledge of labelling software’s
- Interacts with other internal departments when necessary.
- Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance knowledge.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- M Pharmacy, B Pharmacy or Equivalent Degree
- Knowledge, Skills and Abilities
- Basic knowledge and/or understanding of regulatory requirements for filing labelling submissions in USFDA, Health Canada or ROW markets.
- Good interpersonal communication skills
- Demonstrate good writing skills and compilation of submission documents.
- Proofreading ability for reviewing technical documents required for dossier preparation
- Attention to detail to check packaging artwork material and specifications
- Collaborate with team members.
- Other Techniques: Plant tissue culture (seed germination, Direct-Indirect Organogenesis, Micropropagation), Biochemical assays (Protein estimation, Sugar estimation).
- Self motivated, taking responsibility and taking initiative.
- Experience:

- Must have labelling experience in any market - US, Canada, Europe or ROW.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.