Why Patients Need You

The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.

What You Will Achieve

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing product change regulatory strategy to cross-functional project teams while interacting with regulatory agencies to expedite approval of pending variations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle. Your understanding of regulatory procedures will help in development of submission of product progress reports, supplements, variations and periodic experience reports.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing process improvements. You will be able to take a leadership role to facilitate agreements between different teams.

It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients in the EU and across the globe.

How You Will Achieve It

• Lead/contribute to assigned projects as required.
• Maintain EU marketing authorisations in compliance with relevant regulations and guidelines.
• Analyse risk and benefits of viable regulatory options in order to determine strategies for CMC and Labelling updates to EU marketing authorisations which will be successful with the regulatory agencies.
• Manage the preparation of registration packages and responses to deficiency letters.
• Negotiate submission data requirements and deliverable dates with regulatory authorities and internal technical teams.
• Author key pieces of regulatory submissions as necessary.
• Act as a point person for regulatory agency interactions as necessary.
• Support regulatory compliance activities by following assigned SOPs and using relevant change management and commitment tracking systems.
• Maintain awareness of EU and global regulatory legislation and assess its impact on business and product change programs.

QualificationsMust-Have

• Bachelor's Degree (preferably in one of the life sciences)
• Extensive relevant experience
• Experience in Over the Counter or pharmaceutical industry, with experience in the global regulatory environment
• Regional/Country regulatory experience including submission processes and product life cycle management activities
• Knowledge of commercial activities and Current Good Manufacturing Practices (part of GxP)
• Ability to work well cross functionally and to develop productive/collaborative relationships
• Strong written and verbal communication skills

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Experience of conducting, managing or participating in audit processes

The closing deadline for applications is December 1st.

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