Drug Regulatory Affairs

Position: Drug Regulatory Affairs (DRA) Specialist

**Job Description**:
Join our dynamic pharmaceutical team as a Drug Regulatory Affairs Specialist, playing a key role in ensuring compliance with regulatory requirements for our product portfolio. As a DRA Specialist, you will collaborate with cross-functional teams to prepare, submit, and manage regulatory submissions to health authorities. Your responsibilities will include maintaining current knowledge of regulations, tracking regulatory changes, and communicating with regulatory agencies. You'll contribute to the development of regulatory strategies, ensuring timely approvals for new products and maintaining compliance for existing ones. If you're detail-oriented, possess strong analytical skills, and have a background in regulatory affairs within the pharmaceutical industry, we invite you to be a vital part of our mission to deliver innovative and compliant healthcare solutions.

Key Responsibilities:
1. Prepare and submit regulatory documents for product approvals, variations, renewals, and post-approval changes.

2. Collaborate with internal teams to develop regulatory strategies aligned with business objectives.

3. Maintain up-to-date knowledge of regulatory requirements, guidelines, and industry trends.

4. Communicate with health authorities to address queries and facilitate timely approvals.

5. Review and interpret regulatory guidelines to ensure compliance throughout product lifecycle.

6. Participate in regulatory intelligence activities, keeping the organization informed of relevant changes.

7. Contribute to the preparation of regulatory submissions, ensuring accuracy and completeness.

8. Support regulatory inspections and audits, providing necessary documentation as required.

9. Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development plans.

10. Provide regulatory guidance to internal stakeholders, including R&D, quality, and marketing teams.

**Job Types**: Full-time, Permanent

**Salary**: ₹12,166.47 - ₹45,227.46 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Commission pay
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Zirakpur, Punjab (required)

Ability to Relocate:

- Zirakpur, Punjab: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 9053010133