Senior Regulatory Executive - Walton-on-Thames, United Kingdom - Pfizer

Pfizer

Verified Company

Walton-on-Thames, United Kingdom

4 days ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 productbased teams.
Provide regulatory input to commercial strategic and operating planning process.
Attend relevant product team meetings with crossdivisional 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 crossfunctional awareness and understanding of regulatory issues and environment as appropriate.
Keep crossfunctional 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 crossdivisional Pfizer colleagues and direct or indirect interactions with external customers.
Advise on matters of compliance, regulatory requirements, and Pfizer regulatory policy.
Partner with abovecountry 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 abovecountry operational hubs and abovecountry GRA strategists to review, coordinate 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 abovecountry 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 abovecountry operational hubs and abovecountry GRA strategists and with local medical functions.
Work with abovecountry GRA strategists and, abovecountry 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 abovecountry GRA strategist.

Manage and Submit MA Renewal Applications

Prepare agreed Module 1 documents in partnership with abovecountry 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 abovecountry operational hubs and abovecountry GRA strategists, respond to Regulatory Authority queries and input to aggregate safety reports.
Provide calendar data to abovecountry 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