Regulatory Affairs Associate

4 days ago

Greater Noida, India Ocean Bio Med Full time

**Job Summary**:
The Regulatory Affairs Executive is responsible for ensuring compliance with regulatory requirements for pharmaceutical products. This role involves preparing and submitting regulatory documentation, coordinating with internal teams, and maintaining up-to-date knowledge of industry regulations.

**Roles and Responsibilities**:

- Prepare and submit regulatory documents for product approvals and renewals.
- Ensure compliance with local and international regulatory requirements.
- Coordinate with cross-functional teams for data collection and documentation.
- Maintain and update regulatory files and records.
- Liaise with regulatory authorities for approvals and clarifications.
- Review product labeling and packaging to ensure regulatory compliance.
- Monitor changes in regulatory guidelines and inform relevant departments.
- Assist in audits and inspections by regulatory agencies.

**Qualifications**:

- Bachelor’s degree in Pharmacy, Life Sciences, or a related field.
- 2-4 years of experience in regulatory affairs in the pharmaceutical industry.

**Skills Required**:

- Strong knowledge of regulatory requirements and documentation.
- Excellent written and verbal communication skills.
- Attention to detail and strong organizational abilities.
- Ability to work independently and meet deadlines.
- Proficiency in Microsoft Office Suite.

**Experience**:

- 2-4 years of experience in regulatory affairs or a similar role.

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

Pay: ₹11,887.79 - ₹49,420.00 per month

**Benefits**:

- Cell phone reimbursement
- Commuter assistance
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund
- Work from home

Schedule:

- Day shift
- Evening shift
- Fixed shift
- Monday to Friday
- Morning shift

Supplemental Pay:

- Commission pay
- Joining bonus
- Overtime pay
- Performance bonus
- Quarterly bonus
- Shift allowance
- Yearly bonus

Work Location: In person

Application Deadline: 13/03/2025
Expected Start Date: 17/03/2025

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