Assistant Manager Regulatory Affairs

2 weeks ago

Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  1. Regulatory Submissions and Approvals:

  2. Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements.

  3. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions.

  4. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies.

  5. Compliance and Documentation:

  6. Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations).

  7. Maintain accurate and up-to-date records of regulatory documents, approvals, and communications.

  8. Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations.

  9. Labeling and Packaging Compliance:

  10. Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions.

  11. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities.

  12. Product Development Support:

  13. Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development.

  14. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies.

  15. Regulatory Intelligence:

  16. Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions.

  17. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations.

  18. Communication and Coordination:

  19. Act as a point of contact between the company and regulatory bodies in the assigned markets.

  20. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches.

  21. Cross-functional Collaboration:

  22. Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing.

  23. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information.

  24. Product Registration Lifecycle Management:

  25. Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments.

  26. Ensure timely submission of regulatory documents to maintain product approvals and licenses.

  27. Risk Management and Problem-Solving:

  28. Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products.

  29. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions.

Preferred candidate profile

Must have experience in Injectables dosage forms.

Perks and benefits

  • Manager Drug Regulatory Affairs

    2 weeks ago

    Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Role & responsibilitiesRegulatory Strategy Development:Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc.Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these...

  • Power Sector Regulatory Expert

    2 weeks ago

    Panchkula, Haryana, India beBeePower Full time ₹ 8,00,000 - ₹ 12,50,000

    Regulatory Expertise in Power DistributionWe are seeking an experienced professional to assist in the execution of assignments and ensure compliance with directives issued by the State Electricity Regulatory Commission (SERC).The ideal candidate will have a strong technical foundation, excellent communication and collaboration abilities, and the capacity to...

  • Assistant Manager Purchase

    5 days ago

    Panchkula, Haryana, India Mother Sparsh Baby Care private Limited Full time

    Assistant Manager Purchase Position Overview We are seeking an experienced and proactive candidate to oversee purchase and production coordination for Mother Sparsh The ideal candidate will have a strong understanding of raw materials packaging procurement and the production processes within the beauty and skincare industry This role combines...

  • Assistant Manager Purchase

    6 days ago

    Panchkula, Haryana, India Mother Sparsh Baby Care private Limited Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    Job Description:Assistant Manager PurchasePosition Overview:We are seeking an experienced and proactive candidate to oversee purchase and production coordination for Mother Sparsh. The ideal candidate will have a strong understanding of raw materials, packaging procurement, and the production processes within the beauty and skincare industry. This role...

  • Global Commercial Strategist

    2 weeks ago

    Panchkula, Haryana, India beBeeExport Full time US$ 10,00,000 - US$ 15,00,000

    Strategic Export LeaderThe Chief Exports Officer will be entrusted with the strategic and operational command of international commercial business.Main Responsibilities:Drive global pharmaceutical sales and operational excellence.Own full P&L accountability and drive sales revenue across all international markets.Define, cascade, and rigorously monitor...

  • R&D Executive – API Development

    2 weeks ago

    Panchkula, Haryana, India Fido Pharma Pvt. Ltd. Full time ₹ 4,20,000 - ₹ 5,40,000 per year

    About Us:Fido Pharma is a leading pharmaceutical manufacturer committed to ensuring the highest standards of product quality, safety, and compliance. We are seeking a dynamic and motivated R&D Executive – API Development to join our pharmaceutical team.Key Responsibilities:Develop and optimize synthetic routes for APIs in accordance with regulatory and...

  • Chief Export Officer

    2 weeks ago

    Panchkula, Haryana, India Venus Remedies Ltd Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Chief Export Officer - International BusinessThe Chief Exports Officer (CXO) will be entrusted with the strategic and operational command of Venus international commercial business with a primary focus on driving tangible sales and PL ownership. This pivotal role is central to achieving our ambitious global growth targets, not just by identifying...

  • Chief Export Officer

    2 weeks ago

    Panchkula, Haryana, India Venus Remedies Limited Full time

    Chief Exports Officer (International Business) Job Description: Chief Exports Officer Reports To: International Business Leadership Team Leadership: All International Business teams We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately 700 crores and a dedicated team of 1400+ professionals. We are...

  • 3 Days Left: Chief Export Officer

    2 weeks ago

    Panchkula, Haryana, India Venus Remedies Limited Full time

    Position Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...

  • Chief Export Officer

    2 weeks ago

    Panchkula, Haryana, India Venus Remedies Limited Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Position Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...