# Regulatory Affairs

**Company**: Pfizer
**Location**: Delhi, India
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Delhi/Assistant-Manager--Regulatory-Sciences--Evergreen-Position-_4966412?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c8e5d867-13d

## Description

The Regulatory Affairs professional will oversee strategy relating to obtaining, managing, and maintaining product Marketing Authorizations and support Clinical Trial Authorizations in line with business goals and legal requirements.

**Deliver Regulatory Strategy and Advise Cross-Functional Teams:**

- Develop and deliver optimal regulatory strategies and plans to support business goals for Oncology portfolio in India, Indochina, and non-vaccine portfolio in Brunei.

- Represent Regulatory on cross-functional product teams and provide strategic regulatory input.

- Facilitate cross-functional awareness of regulatory issues and environment.

**Provide Regulatory Advice and Information:**

- Provide insightful responses to enquiries from cross-divisional Pfizer colleagues and external customers using expert knowledge of national legislation and regulatory environment.

- Advise on compliance, national regulatory requirements, and Pfizer regulatory policy.

**Manage New Registration/Marketing Authorization Applications:**

- Coordinate pre-submission meetings and NRA engagements.

- Devise and obtain endorsement for submission strategy and plan.

**Manage Marketing Authorisation (MA) Variation Applications:**

- Trigger locally driven submission demands.

- Input to assessing regulatory impact and agree filing strategy.

**Manage MA Renewal Applications:**

- Agree filing strategy with relevant stakeholders.

**Management of NRA Queries:**

- Respond to NRA queries in partnership with above-country operational hubs and strategists.

**External Relationships:**

- Develop and enhance working relationships with Regulatory Authorities and trade associations.

- Develop influencing strategies to negotiate optimal outcomes.

**Clinical Trials:**

- Support strategic clinical development activities in partnership with national Regulatory Authorities.

**Populate and Maintain Regulatory Databases:**

- Perform database entry and document management for regulatory transactions.

**Obtain NRA Approvals for Supply of Unlicensed Medicines:**

- Facilitate NRA approval for supply/import of unlicensed Pfizer medicines.

**Safeguard Compliance in the Management of Packaging and Prescribing Information Component Updates:**

- Notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information.

**Devices:**

- Support regulatory activities for medical devices if required.

**Contribute to Good Regulatory Practice (GRP):**

- Adhere to relevant procedures and practices to ensure GRP is maintained.

**Support Regulatory Group Development:**

- Contribute to and support the maintenance and development of the cluster/country Regulatory team.

**Lead Personal Development and Support Coaching/Mentoring of Team Members:**

- Identify own training and development needs and act as a senior mentor/coach for less experienced colleagues.

**Regulatory Team Support:**

- Oversee assigned contractors and ensure regulatory team members work effectively in a productive and well-motivated environment.

## Skills

### Required
- regulatory affairs
- clinical trials
- marketing authorization
- regulatory strategy

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Delhi/Assistant-Manager--Regulatory-Sciences--Evergreen-Position-_4966412?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)