Junior Associate - Compliance

Pfizer Inc.; Tadworth; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Disability Confident Employer

Job summary

Pfizer Inc. in the United Kingdom is seeking an experienced Regulatory professional to conduct strategic regulatory activities for assigned products and markets, aiming to obtain and maintain Marketing Authorizations and support Clinical Trial Applications where applicable.

Under guidance from a Senior Regulatory Manager, you will deliver regulatory strategy, advise cross-functional teams, maintain regulatory databases, and ensure compliance, contributing to Pfizer's drug development and

Qualifications

• Must have regulatory experience in Human Medicinal Products.
• Computer literacy required.

Responsibilities

• Deliver Regulatory Strategy and Advise Cross-Functional Teams.
• Provide Regulatory Advice and Information to meet requests.
• Inform assigned product regulatory strategies.
• Share updates and regulatory intelligence with colleagues.
• Seek authority advice/clarification when regulatory position is unclear.
• Support strategic clinical development activities with regulatory authorities and CTRSE as applicable.
• Populate and Maintain Regulatory Databases.
• Safeguard Compliance in management of packaging and PI updates.
• Support regulatory activities for medical devices if required.
• Contribute to Good Regulatory Practice (GRP).
• Support Regulatory Group Development.

Skills

Previous regulatory experience

Computer literacy

Education

Life sciences or chemistry graduate (to honours)

Master's degree, Post Graduate Diploma or PhD preferred

MSc in Regulatory

Job description

n Under the supervision of line management or guidance from an experienced Senior Regulatory Manager, conduct agreed strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.

Key Responsibilities

• Deliver Regulatory Strategy and Advise Cross-Functional Teams
• Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
• Inform assigned product regulatory strategies.
• Share updates and regulatory intelligence with colleagues.
• Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
• Support the strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable.
• Populate and Maintain Regulatory Databases
• Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates
• Support regulatory activities for the development and maintenance of medical devices if required.
• Contribute to Good Regulatory Practice (GRP)
• Support Regulatory Group Development

Requirements

• Life sciences or chemistry graduate to honors level or equivalent
• Master's degree, Post Graduate Diploma or PhD preferred
• MSc in Regulatory
• Previous experience and proven track record in Regulatory (Human Medicinal Products)
• Computer literacy

n 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 is committed to celebrating this, in all its forms 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!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs