JOB SUMMARY

This is an individual contributor / career development role, with room to grow into managing direct reports. The role entails strategy, working on own initiative and taking on projects, as detailed below.

There will be opportunities to lead, motivate, inspire and develop direct reports; management of projects and strategy at a departmental level; management of permanent staff and contractors; contributing to the strategic regulatory input into cross-functional product teams for licensed and development products and the implementation of special projects for country markets; overseeing the management of Clinical Trial Authorizations (where applicable), new Marketing Authorizations and maintenance activities; monitor team performance to ensure colleagues fully comply with Company and statutory tasks and compliance obligations and provision of regulatory advice to, and liaison with, key customers and relevant stakeholders.

Allow Pfizer to legally study, manufacture, market and supply medicines. To obtain, manage and maintain product Marketing Authorizations and Clinical Trial Authorizations in line with business goals and legal requirements. 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.

Work Location Assignment: Flexible (Walton Oaks, Surrey or Watermarque, Dublin)

RESPONSIBILITIES :

Department & Project Management

To be accountable for identifying, implementing and managing key Regulatory Departmental projects either on an individual basis or as part of the Regulatory Management Team, based on both short and long term Regulatory Department objectives including agreement of relative project priorities with Head of Regulatory Sciences as appropriate.

To play a lead role in ensuring that the Regulatory Department has effective and efficient processes in place.

To participate in/lead, cross-functional project teams, to address business needs in line with Global/Regional GRS and UK/Irish business objectives and strategic imperatives.

To monitor regulatory activities across product therapy areas in accordance with reporting lines and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements and timelines.

Deputize for Head of Regulatory Sciences as required. 

People and Resource Management

Manage performance of direct reports to achieve established objectives, with high quality outputs, and to identify and address training and development needs.

Ensure regulatory team members work effectively in a productive and well motivated environment through providing ongoing coaching, guidance and relaying of regulatory expertise.

Ensure direct reports are assisted and that direct reports have a manageable workload through redistribution, prioritization or outsourcing of work, as necessary including planning of appropriate timelines and resource allocation.  Include consideration of individual strengths when allocated project/product tasks.

Participate in the recruitment of new staff as required.

Ensure systems are in place and adhered to, to optimize process efficiency.

Contribute to Cross-functional Teams and Build Regulatory Expertise.

In line with defined product responsibilities, utilize regulatory expertise to develop and deliver optimal regulatory strategies and plans to assist the achievement of country business goals for both licensed and development product.

Represent Regulatory 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 assistance for teams as necessary. Ensure teams comprehend 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 GRS regional strategists to provide country specific 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 replies to enquiries from Pfizer cross-divisional 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 Authorization Applications:

National/MRP/Decentralised  MAA: Partner with above-country operational  hubs and above-country strategists to review, co-ordinate and, where required, create necessary technical data to assist country submissions e.g. provide national specific module 1 data review & approve proposed regulated documents (SPC, PIL & Labelling) & 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 Module 1 documents in partnership with above-country operational hubs. Review data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.

Prepare Module 2 documents in partnership with above-country operational hubs, above-country strategists and 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.

Lead MRP/DCP submission review and planning where country is RMS, in conjunction with above-country strategist.

Manage and Submit MA Renewal Applications

Prepare 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, reply to Regulatory Authority queries and input to aggregate safety reports.

Provide calendar data to above-country operational hubs, as needed.

Devices

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

Influence Regulatory Authorities

Develop and 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.

Utilize local knowledge of Regulatory Authority’s expectations, ways of working etc to appropriately direct company strategy. Relay updates with colleagues.

Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.

Reply 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 (if performed in country)

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 established CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including reply to Regulatory Authority queries.

Ensure timely communication of any GCP breaches, or actions taken for safety reasons.   

Populate and Maintain Regulatory Databases

Accountable for database entry and the document management of regulatory transactions undertaken at local level.

Accountable 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 and 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  license

Secure license 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: Organize internal approval to cancel the license(s) and identify appropriate candidates and timing as part of lifecycle management.

Prepare and submit request to Regulatory Authorities to cancel license(s)

Notify relevant colleagues of approval of the license cancellations (s)

Interruptions to Supply: In line with the current process, lead cross functional meetings to explore options to help minimize 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, WIs and Job Aids) to ensure GRP is maintained.

Monitor existing processes and drive changes to processes to improve them as necessary.

Through maintenance of regulatory activities in line with company procedures for own products, contribute to “inspection ready” state.

Lead Personal & Team Development

Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximize/optimize career development and contribution to the business.

Develop product and therapeutic area knowledge as needed, according to product responsibilities list.

With support of Manager build on competency strengths and address  development areas

Support IDPs for direct reports.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

• Life sciences or chemistry graduate to honors level or equivalent
• Masters Degree, Post Graduate Diploma or PhD preferred
• Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory)
• Member of The Organization for Professionals in Regulatory Sciences (TOPRS)
• Previous experience and proven track record in Regulatory (Human Medicinal Products)
• Previous experience and demonstrated line management capability and/or experience of coaching and mentoring
• Computer literacy
• Excellent written and verbal communication skills
• Proven strength in analytical thinking
• Leadership capability

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

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.

Flexibility  

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. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!