Senior Regulatory Associate

Pfizer Inc.; England; In loco; GBP 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Pfizer Inc. is seeking regulatory affairs professionals to support development, maintenance, and compliance for medicinal products and medical devices in the UK.

You will work with national regulators, ensure accurate labeling and regulatory documentation, and assist with approvals for unlicensed medicines as needed. The role emphasizes strong written and verbal communication, analytical thinking, and a proven regulatory track record, with eligibility to work in the United Kingdom.

Competenze

• Life sciences or chemistry degree with honors; MSc/PhD preferred.
• Professional regulatory qualifications desirable (e.g., MSc in Regulatory).
• Proven experience and track record in Regulatory (Human Medicinal Products).
• Excellent written and verbal communication skills.
• All applicants must have authorization to live and work in the UK.

Mansioni

• Support regulatory activities for development and maintenance of medicines and medical devices as applicable.
• Obtain NRA approvals for supply of unlicensed medicines (Named Patient/Compassionate Use).
• Maintain regulatory databases and ensure compliance in packaging and prescribing information updates.
• Support MA divestments, MA cancellations, product discontinuations and supply continuity.
• Contribute to Good Regulatory Practice (GRP) and regulatory group development.

Conoscenze

Regulatory knowledge

Regulatory submissions

Communication skills

Analytical thinking

Formazione

Life sciences/chemistry degree

Master's/PhD or regulatory qualification

Strumenti

Computer literacy

Descrizione del lavoro

position unclear and answers are not available through internal network. Respond to spontaneous requests from authorities promptly and accurately. 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 Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use) Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity Support Third Party Licenses Support regulatory activities for the development and maintenance of medical devices if required. Contribute to Good Regulatory Practice (GRP) Support Regulatory Group Development Lead Personal Development

QUALIFICATIONS / SKILLS

Life sciences or chemistry graduate to honors level or equivalent Master's degree, Post Graduate Diploma or PhD preferred Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory), Previous experience and proven track record in Regulatory (Human Medicinal Products) Computer literacy Excellent written and verbal communication skills Proven strength in analytical thinking All applicants must have the relevant authorization to live and work in the UK.

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.

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!

Regulatory Affairs

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.