Regulatory Affairs and Quality Control Executive - United Kingdom - Pfizer

Description

Senior Regulatory Executive page is loaded Senior Regulatory Executive
Apply locations United Kingdom - Walton Oaks time type Full time posted on Posted Yesterday job requisition id 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 on product based teams.
Provide regulatory input to commercial strategic and operating planning process.

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 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.

Partner with above-country operational hubs and above-country strategists to review, co-ordinate and, where required , create necessary technical data to support country submissions e.g.

provide national specific module 1 data. Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. 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 strategists and with local medical functions.

Work with above-country 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.

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 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.
Utilize local knowledge of Regulatory authority's expectations, ways of working etc to appropriately direct company strategy. Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
Liaise with clinical research project managers to seek to understand clinical research programme .

In partnership with above-country operational hubs, above-country 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.

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 .
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
In partnership with above-country operational hubs, above-country 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.

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 strategists and with local medical functions.

Work with above-country 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.

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 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.
Utilize local knowledge of Regulatory authority's expectations, ways of working etc to appropriately direct company strategy. Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
Liaise with clinical research project managers to seek to understand clinical research programme .

In partnership with above-country operational hubs, above-country 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.

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 .
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
In partnership with above-country operational hubs, above-country 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.

Advise business on regulatory activities required prior to divestment/transfer of licence Secure licence transfer.

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.
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).

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)
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 Group Development

Contribute to and support as necessary, the maintenance and development of the Regulatory group through pro-active involvement and participation and in some instances, leading of special projects; Support development of regulatory colleagues by sharing relevant knowledge and experience.

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.

Support regulatory activities for the development and maintenance of medical devices including acting as EU Authorised Representative if required .

Life sciences or chemistry graduate to honours level or equivalent
Masters Degree , Post Graduate Diploma or PhD preferred
MSc in Regulatory)
Previous experience and proven track record in Regulatory (Human Medicinal Products)
Member of The Organisation for Professionals in Regulatory Sciences (TOPR S ) preferred.
Computer literacy
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy.

We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

We believe that a diverse and inclusive workforce is crucial to building a successful business.

As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career.

Your journey with Pfizer starts here
Regulatory Affairs About Us
Pfizer careers are like no other.

In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.

We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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