Job Description:
The Regulatory Manager will lead strategic regulatory activities for assigned products and marketstoobtainandmaintainMarketingAuthorizationsand support Clinical TrialApplications(where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.Contribute to the implementation and leadership of projects and buildingexpertisewithin the cluster regulatory team.

JOB RESPONSIBILITIES

Deliver Regulatory Strategyand Advise Cross-Functional Teams

• For assigned product and market responsibilities,develop anddeliveroptimalregulatory 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 asrequired.

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

• Use expert knowledge of national legislation,guidelinesandregulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and indirect interactions with external customers.
• Advise on matters of compliance,nationalregulatoryrequirementsand Pfizer regulatory policy.

ManageNew Registration/MarketingAuthorizationApplications:

National Applications

• Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EUnationalScientific Advice Meetings.
• Devise and obtain endorsement for submission strategy and plan and partner with above-countryoperational hubsand above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs.

For EU

MRP/DecentralisedMAAs:

• Partnerwith above-country operational hubs and above-country strategists to review and whererequired, provide country specific module 1 data.

CentralizedMAAs

• Facilitate local launch date planning and NRA approval ofadditionalrisk minimization measures, as applicable.

Manage MarketingAuthorization (MA)Variation Applications

• Trigger locally driven submission demands (e.g.NRAqueries andrequests forlocal label updates).
• Input to assessingregulatory impact, agree filing strategy with other business functions asappropriateandparticipateinrisk-based reviewswith above-country hubsand communicate any locally triggered delays & risksimpactingthe submission/approval, to the aboveand in-countrystakeholders.
• Work with above-country strategists and above-country operational hubs to supply country documentation/informationfor dossier buildas applicable.
• CommunicateNRAdecisions to relevant internal stakeholders as applicable.

EUMarkets

• Support EURegulatory Strategistwithsubmissionstrategy negotiation withReference Member State (RMS)Regulatory authoritiesandmanagecontactwithConcerned Member State (CMS)Regulatory authorities.

Manage MA Renewal Applications

• Agree filing strategy withrelevant stakeholdersasappropriateandparticipatein risk-based reviewsof planswith above country hubs.

Management ofNRAqueries

• In partnership with above-country operational hubs and above-country strategists, respond toNRAqueries.

External Relationships

• Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations.
• Develop and enactappropriate influencingstrategiesin order tonegotiateoptimaloutcomes for the business on product issues.
• Utilizeknowledge of NRAs expectations, ways ofworkingetc.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.

Clinical Trials

Support the following strategic clinical development activities in partnership withnational Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable:

• Optimization of Clinical Development Plan (CDP) and Country Footprint.

• Communications with NRAs to clarify questions during assessment as required by CTRSE.

• Support Regulatory Requirements Manager (RRM) updates for local Clinical Trial Applications (CTAs) and study conduct requirements.

• Participation in national CTA Trade Association working groups and advocacy activities.

Additionally for EU countries only:

• Selectionof Reporting Member State (RMS).

• Support contact with RMS and Concerned Member State (CMS)national Regulatory Authorities asrequiredfor any scientific interaction at a program (Scientific Advice) or study level (Pre-CTA/Pre-vetting meetings).

Populate and Maintain Regulatory Databases

Perform database entry and the document management for regulatory transactions undertaken by CountryRegulatoryStrategists, in line with global SOPs, if applicableand not performed by above country operational hubs.

ObtainNRAApprovals for Supply of Unlicensed Medicines

• Following a request from a prescriber and internal approval toproceedwith supply of unlicensed Pfizer medicines to address unmet patient needs,facilitateNRAapproval for supply/import via above countryoperationalhubs.

Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates

• Via defined procedures notify relevant internal stakeholders ofNRAapproval 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 stakeholdersand above country operational Hubs, where applicable:

• Divestments:Advisebusiness on regulatory activitiesrequiredprior to divestment/transfer of license. Support license transfer.
• Discontinuations:Liaise with local Commercial/Medical/Demand functions and advise on regulatory actionrequiredfor discontinuation of a product in the country marketplace.
• Upon receipt of above-county endorsement toproceed, trigger applicable notification toNRAand other external stakeholders as required by national regulations.
• Cancellations: Upon receipt of in and above-county endorsement toproceed, manage applicable notification/request toNRA, as required by national regulations.
• Notify relevant colleagues of approval of the license cancellation.
• Interruptions to Supply: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 minimize or mitigate the out of stock. Obtain the necessaryNRAapproval asrequiredandpartner with above-country Operational Hubs as applicable.

Support Third Party Licenses

• Manage relevant, local regulatory activities related to supporting third party licenses for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs.

Devices

• Support regulatory activities for the development and maintenance of medical devices ifrequired.

Contribute to Good Regulatory Practice(GRP)

• Adhere to relevant procedures and practices (SOPs, JobAidsand WIs) to ensure GRP ismaintained.
• Helpidentifychanges to business processes to improve them as necessary, includingto reflectchanges in regulations.
• 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 thecluster/countryRegulatoryteamthrough pro-active involvement and participation and in some instances, leading of specialprojects;e.g. development of new operating procedures.
• Support drive towards Pfizer and GRS Vision and Values.

Lead Personal Development

• Identifyown 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 ofline managementbuild on competency strengths and address any development areas.
• Act as a senior mentor/coach for less experienced colleagues.

Work Location Assignment: Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives... At Pfizer we are apatient 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.Lets 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!

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