Regulatory Affairs Officer

Job Title: Senior Executive - Regulatory Affairs UK/IE/MT

Department: Regulatory Affairs

Grade Level: P-2

Reports to: Manager / Sr. Manager
- Regulatory Affairs

Number of Reports: NONE

Location: Mumbai

**Main purpose of role**:
To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements.

**Key Responsibilities**:
1. Planning and preparation for Renewals / annual maintenance of MA’s assigned; ensure all regulatory requirements of health authorities are met and supply continuity for the products are maintained.

a. Ensure informing stakeholders (internal & external) and request of document(s), information sufficiently ahead of time, proactively following up for timely delivery

b. Detailed review of document to ensure it meets regulatory requirement

c. Preparation of regulatory submission with a focus on right first time without any further review of line manager

d. Coordination with stakeholders (publishing team, regulatory partner, internal stakeholders or health authorities) to ensure submission before due dates

e. Following up on approval, prompt responses to any request for information ensuring timely approval and carrying out necessary post approval activities as defined in regulatory procedures

2. Assessing Change request assigned to ensure regulatory assessment along with strategy and documents required for any regulatory submissions are shared with stakeholder in a timely fashion.

a. Plan and prioritise variation submissions based on nature/ criticality of change using information available (for example supply impact, compliance risk etc)

b. Following up for documents from necessary stakeholders, reviewing documents to ensure it meets the regulatory requirements and address any gaps that may exist

c. Preparation of regulatory submission with a focus on right first time without any further review of line manager

d. Coordination with stakeholders (publishing team, regulatory partner, internal stakeholders or health authorities) to ensure submission before due dates

e. Following up on approval, prompt responses to any request for information ensuring timely approval and carrying out necessary post approval activities as defined in regulatory procedures

4. Provide peer review support as and when required for submissions made by Executives and other Sr. Executives

5. Ensure prompt action in terms of compliance to departmental procedures, ensure up to date training records for self, and regulatory databases are kept up to date as stipulated in internal procedures

6. Actively drive continuous improvement initiative for team/ function as and when delegated

7. Actively drive simple to moderately complex regulatory projects (functional or cross functional)

8. Act as process owners for simple to moderately complex regulatory procedures, ensure lifecycle of the procedure taking ownership for engaging with team to train and improve upon as and when needed

9. Support Line Managers for readiness and participation of any health authority inspection

10. Actively involved in knowledge sharing and best practices across teaM/Function and cross functional teams when required

11. To support/perform the submissions of the acquired products as part of acquisition and integration as an when required and their maintenance of lifecycle.

12. Ensure timely completion of assigned Deviations and CAPAs

13. Provide timely responses to Cross Functional Teams.

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

**Salary**: ₹600,000.00 - ₹1,200,000.00 per year

Schedule:

- Day shift
- Monday to Friday
- Weekend availability

**Experience**:

- total work: 1 year (preferred)

Work Location: In person