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34 Venus Remedies Jobs

Assistant Manager Regulatory Affairs

5-10 years

Panchkula

1 vacancy

Assistant Manager Regulatory Affairs

Venus Remedies

posted 22hr ago

Job Description

Role & responsibilities


1. Regulatory Submissions and Approvals:

  • Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements.
  • Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions.
  • Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies.

2. Compliance and Documentation:

  • Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations).
  • Maintain accurate and up-to-date records of regulatory documents, approvals, and communications.
  • Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations.

3. Labeling and Packaging Compliance:

  • Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions.
  • Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities.

4. Product Development Support:

  • Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development.
  • Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies.

5. Regulatory Intelligence:

  • Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions.
  • Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations.

6. Communication and Coordination:

  • Act as a point of contact between the company and regulatory bodies in the assigned markets.
  • Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches.

7. Cross-functional Collaboration:

  • Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing.
  • Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information.

8. Product Registration Lifecycle Management:

  • Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments.
  • Ensure timely submission of regulatory documents to maintain product approvals and licenses.

9. Risk Management and Problem-Solving:

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




Employment Type: Full Time, Permanent

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What people at Venus Remedies are saying

Assistant Manager Regulatory Affairs salary at Venus Remedies

reported by 3 employees with 4-8 years exp.
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₹3 L/yr - ₹8 L/yr
44% less than the average Assistant Manager Regulatory Affairs Salary in India
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What Venus Remedies employees are saying about work life

based on 313 employees
57%
89%
40%
99%
Strict timing
Monday to Saturday
No travel
Day Shift
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Venus Remedies Benefits

Submitted by Company
Health Insurance
Soft Skill Training
Free Transport
Cafeteria
Submitted by Employees
Job Training
Free Transport
Soft Skill Training
Health Insurance
Free Food
Cafeteria +6 more
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Venus Remedies Panchkula Office Location

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Panchkula, Haryana Office
Headquarter
51-52, Industrial Area, Phase-I, Panchkula ( Haryana) Panchkula, Haryana
134113

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