Senior Regulatory Executive

Pfizer
Job Description – Senior Regulatory Executive

JOB SUMMARY

To allow Pfizer to legally study, manufacture, market, and supply medicines. To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements. Under the guidance and supervision of line management, to conduct associated regulatory activities for the specified markets, and to contribute to the implementation and leading of projects and building of expertise within the Regulatory Department.

JOB RESPONSIBILITIES

Contribute to Cross-functional Teams and Build Regulatory Expertise.

• In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
• Represent Regulatory Affairs on product-based teams.
• Provide regulatory input to commercial strategic and operating planning process.
• Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
• Build personal expertise through management of specified products within one or more therapy areas.
• Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
• Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
• Work with GRA regional strategists to provide country input into Global and European Regulatory Strategies as required.
• Seek to improve alignment of local and regional regulatory strategy and tactics.

Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.

• Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and direct or indirect interactions with external customers.
• Advise on matters of compliance, regulatory requirements, and Pfizer regulatory policy.
• Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.

Manage and Submit Marketing Authorisation Applications:

National/MRP/Decentralised MAA:

• Partner with above-country operational hubs and above-country GRA strategists to review, co-ordinate and, where required, create necessary technical data to support country submissions e.g. provide national specific module 1 data. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.

Centralised MAA

• Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.

Manage and Submit MA Variation Applications

• Prepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.
• Prepare agreed Module 2 documents in partnership with above-country operational hubs and above-country GRA strategists and with local medical functions.
• Work with above-country GRA strategists and, above-country operational hubs to supply country documentation to support Centralised product variations and to ensure effective coordination of Mutual Recognition and Decentralised variations.
• Lead MRP submission review and planning where country is RMS, in conjunction with above-country GRA strategist.

Manage and Submit MA Renewal Applications

• Prepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements.

Management of Safety Reports and Issues with Regulatory Authorities

• In partnership with above-country operational hubs and above-country GRA strategists, respond to Regulatory Authority queries and input to aggregate safety reports.
• Provide calendar data to above-country operational hubs, as needed.

Influence Regulatory Authorities

• 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 local knowledge of Regulatory authority’s expectations, ways of working etc to appropriately direct company strategy. Share updates with colleagues.
• Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
• Respond to spontaneous requests from authorities promptly and accurately.
• Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.

Manage Clinical Trial Approvals

• Liaise with clinical research project managers to seek to understand clinical research programme.
• In partnership with above-country operational hubs, above-country GRA strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including repose to Regulatory Authority queries.
• Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
• Populate and Maintain Regulatory Databases
• Responsible for database entry and the document management of regulatory transactions undertaken at local level.
• Responsible for database entry and archival of regulatory material required at local level.
• Participate in ad hoc and routine QC checking of regulatory data bases.

Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)

• Following a request from a prescriber and corporate approval, obtain necessary approvals to import and supply unlicensed Pfizer medicines to address unmet patient needs.

Safeguard Compliance and Manage Packaging and Prescribing Information Component updates

• In partnership with above-country operational hubs, above-country GRA strategists, and local stakeholders (e.g. Demand Management, logistics, medical, commercial, quality), manage packaging, artwork and labelling components to ensure their introduction within regulatory compliance timelines.
• Via defined procedures notify relevant internal customers of changes to packaging components and prescribing information the timelines for associated implementation activities.
• Dictate compliance timelines when necessary.

Implement MA Divestments, Cancellations and product Discontinuations

Divestments: Advise business on regulatory activities required prior to divestment/transfer of licence

• Secure licence transfer.

Discontinuations: Liaise with product team/commercial/medical functions and advise on regulatory action required for discontinuation of a product in the country marketplace.

• Prepare and submit application to discontinue product to Regulatory Authorities and notify intent to discontinue a medicine to the Ministry of Health. Act as liaison with Regulatory Authority/ministry of health.

Cancellations: Organise internal approval to cancel the licence(s) and identify appropriate candidates and timing as part of lifecycle management.

• Prepare and submit request to regulatory authorities to cancel licence(s).
• Notify relevant colleagues of approval of the licence cancellation (s).

Interruptions to Supply: In line with the current process, lead cross functional meetings to explore options to help minimise or mitigate the out of stock. Obtain the necessary regulatory approval as required.

• Notify Ministry of Health and Regulatory Authorities of interruptions to supply as agreed with cross functional team.
• Contribute to Good Regulatory Practice (appropriate for all tasks)
• Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained.
• Monitor existing processes and drive changes to processes to improve them as necessary.
• Lead by example, guiding more junior colleagues in relation to best practice and required procedures.
• Through maintenance of regulatory activities in line with company procedures for own products, contribute to “inspection ready” state.

Support Regulatory Affairs Group Development

• Contribute to and support as necessary, the maintenance and development of the Regulatory Affairs group 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 GRA Vision and Values.
• Mentor other team members.
• Support development of regulatory colleagues by sharing relevant knowledge and experience.

Lead Personal Development

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