Pfizer
Philippines - Makati City
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. Facilitate cross-functional awareness and understanding of regulatory issues and environment, including ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities. Work with above country strategists to provide country input into Global and Regional regulatory strategies as required.
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.
Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EU national Scientific Advice Meetings. 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 associated interactions and negotiations with NRAs.
Manage Marketing Authorisation (MA) Variation Applications
Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates). Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders. Work with above-country strategists and above-country operational hubs to supply country documentation/information for dossier build as applicable. Communicate NRA decisions to relevant internal stakeholders as applicable.
Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs.
In partnership with above-country operational hubs and above-country strategists, respond to NRA queries.
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. Utilise knowledge of NRA’s expectations, ways of working etc to appropriately direct company strategy. Share updates and regulatory intelligence with colleagues. Work with authorities if Pfizer position differs from authority position to obtain a better outcome for the business/patients.
Perform database entry and the document management for regulatory transactions undertaken by Country Regulatory Strategists, in line with global SOPs, if applicable and not performed by above country operational hubs.
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 to address unmet patient needs, facilitate NRA approval for supply/import via above country operational hubs.
Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities. Negotiate extensions to packaging artwork implementation with Regulatory Authorities when applicable.
Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity Working with local stakeholders and above country operational Hubs, where applicable:
Advise business on regulatory activities required prior to divestment/transfer of licence. Support licence transfer.
Liaise with localCommercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace. Upon receipt of above-county endorsement to proceed, trigger applicable notification to NRA and other external stakeholders as required by national regulations.
Upon receipt of in and above-county endorsement to proceed, manage applicable notification/request to NRA, as required by national regulations. Notify relevant colleagues of approval of the licence cancellation.
Notify Regulatory Authorities of interruptions to supply in accord with national regulations and as agreed with cross functional team. Work with cross functional team to explore options to help minimise or mitigate the out of stock. Obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable.
Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs.
Support regulatory activities for the development and maintenance of medical devices if required.
Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained. Help identify changes to business processes to improve them as necessary, including to reflect changes in regulations. Through maintenance of regulatory activities in line with company procedures for own products, contribute to “inspection ready” state.
Contribute to and support as necessary, the maintenance and development of the cluster/country Regulatory team through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures. Support drive towards Pfizer and GRS Vision and Values.
Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximise/optimise career development and contribution to the business. Develop product and therapeutic area knowledge as needed, according to product responsibilities list. With support of line management build on competency strengths and address any development areas.
Work Location Assignment: Hybrid
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Regulatory Affairs