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.