Description
Deliver Regulatory Strategy and Advise Cross-Functional Teams
For assigned product and market responsibilities, develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products. Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process. Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
Use expert knowledge of national legislation, guidelines and regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and indirect interactions with external customers. Advise on matters of compliance, national regulatory requirements and Pfizer regulatory policy.
Manage New Registration/Marketing Authorisation Applications: National Applications
Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements. Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses.
Manage Marketing Authorisation (MA) Variation Applications
Trigger locally driven submission demands. Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs.
Manage MA Renewal Applications
Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs.
Management of NRA queries
In partnership with above-country operational hubs and above-country strategists, respond to NRA queries.
External Relationships
Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations. Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
Populate and Maintain Regulatory Databases
Perform database entry and the document management for regulatory transactions undertaken by Country Regulatory Strategists.
Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
Following a request from a prescriber and internal approval to proceed with supply of unlicensed Pfizer medicines, facilitate NRA approval for supply/import.
Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates
Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information.
Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
Working with local stakeholders and above country operational Hubs, advise business on regulatory activities required prior to divestment/transfer of licence.
Support Third Party Licences
Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual obligation.
Devices
Support regulatory activities for the development and maintenance of 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
Identify own training and development needs in discussion with Manager.
Qualifications/ skills:
- Graduate of Bachelor of Science in Pharmacy or equivalent
- Registered Pharmacist in the Philippines
- Minimum of 6 years solid working experience in the field of regulatory sciences
- Proven ability to consistently deliver to time, cost and quality standards
- Fluent in English – written and spoken communication skills
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle
- Proven ability to manage regulatory issues
- Regional regulatory experience including knowledge of CTA’s and NDA submission processes
- General management experience and previous line management and leadership experience maybe an added advantage