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 (include but not limited to)

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.

Build personal expertise through management of specified products within one or more therapy areas.

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 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.

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

In partnership with above-country operational hubs and above-country GRA strategists, respond to Regulatory Authority queries and input to aggregate safety reports.

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.

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

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

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.



QUALIFICATIONS / SKILLS

• Life sciences or chemistry graduate to honours level or equivalent
• Masters Degree, Post Graduate Diploma or PhD preferred
• Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
• Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
• Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
• Computer literacy
• Excellent written and verbal communication skills
• Proven strength in analytical thinking

The closing deadline for applications is August 23rd.

All applicants must have the relevant authorisation to live and work in the UK.