Executive Regulatory Affairs

3 weeks ago

Mumbai Maharashtra, India Johnson & Johnson Full time

**Executive Packaging & Regulatory Affairs**

Designation of Employee: Sr. Executive
Functional Department: Regulatory Affairs
Reporting to: Associate Director /Sr. Manager - Regulatory Affairs

**Responsibilities**:Packaging
1. Technology Transfer
- Lead the activities involved in the technology transfer from packaging perspective:

To support packaging material characterisation (Engineering Study), Shipping Qualification

(Physical), Oversee Packaging validation.

Prepare and review Protocols & reports, Development of Artworks, Master Packing Records

2. Packaging material development:

- Prepare specifications for primary, secondary, tertiary & ancillary packaging materials.

3. Preparation of Master Packaging Record (MPR):

- Manage Master Packaging Record review.
- Issue the certified copies of MPR to relevant stake holders as well as manufacturing site.
- Documentation like Master copy, Certified copy and Obsolete copies.

4. Approvals of printed packaging materials:

- Checking proofs/shade cards of packaging materials against approved artworks.
- Management of documentation and distribution of approved proofs/shade cards.

5. Document management
- Keep the record of Approved Artworks & Proofs, Certified MPR in individual product files.
- Keep the records of imported product artworks in individual product files.
- Keep the records of packaging material codes for all printed packaging materials.

**Job Responsibilities: Regulatory Affairs
**Established Products

2. Maintain current knowledge base of existing and emerging regulations, standards, or guidance
documents.

3. Applicable knowledge of D&C Act, NDPS Act, Legal Metrology Rules etc.

4. Preparation of additional information or responses as requested by regulatory agencies

5. Prepare or maintain technical files as necessary to obtain and sustain product approval.

6. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

certifications: WHO-COPP, GMP, GLP, No Conviction Certificate, Manufacturing & Marketing
Certificate, Performance Certificate, Import and Marketing Certificate, Market Standing
Certificate.

8. Management of Testing of Samples at private and government laboratories such as CDTL, NIB,
IPC.

9. Co-ordination with EM sites for P2P and Loan License products with respect to grant of fresh and
renewal of licenses.

10. Supporting RA activities for management of product lifecycle management and NPI for cluster
countries

11. Conversant with eSugam portal of CDSCO/DCGI and XLN portal of various state FDA.

12. Other responsibilities as assigned which covers to review and retrieve data from Public Domain.

13. Maintenance of Tracker of all various activities, status of submissions and approvals.

**Additional Requirements**
- Responsible for effective interaction with team members and support functions at various levels

in the organization.
- Ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
- Responsible for interaction & collaboration for effective implementation of responsibilities.
- Efficient in Computer skills, Management Reporting and Administrative skills, Communication

skills.

The above statements are intended to describe the general nature and level of work being performed.

They are not intended to be construed as an exhaustive list of all responsibilities.

**Qualifications**:
Educational Qualification:

- B. Pharm, M. Pharm, M.Sc. (Chemistry)
- Preferred having: Diploma in Packaging, Diploma in Regulatory Affairs

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