Senior Regulatory Associate

Pfizer Inc.; Knaphill; On-site; GBP 60,000 - 80,000; Full time

Job summary

Pfizer Inc. is seeking a Regulatory Affairs Specialist to navigate regulatory landscapes for our medicines.

You will conduct strategic regulatory activities to secure and maintain Marketing Authorizations, support Clinical Trial Applications, and align with business and legal requirements under guidance from experienced leaders. You will advise cross-functional teams, manage registrations and renewals, respond to NRA queries, keep regulatory databases up to date, and contribute to good

Qualifications

• Degree in life sciences or chemistry (honors level or equivalent).
• Master's degree, Post Graduate Diploma, or PhD preferred.
• MSc in Regulatory or similar qualification.
• Experience in Regulatory Affairs for Human Medicinal Products.
• Strong computer literacy and excellent communication skills.
• Proven analytical thinking ability.

Responsibilities

• Advise cross-functional teams on regulatory strategy to ensure compliance and success.
• Manage New Registration, Marketing Authorization, and Renewal Applications.
• Address NRA queries efficiently and accurately.
• Maintain regulatory databases up to date and ensure data integrity.
• Support Clinical Development with national Regulators and strategists.
• Ensure updates to packaging and prescribing information are compliant.
• Contribute to Good Regulatory Practice and regulatory process improvements.
• Lead personal development and continuous learning.

Skills

Analytical thinking

Regulatory knowledge

Communication skills

Education

Life sciences or chemistry degree

Master's degree or PhD preferred

MSc in Regulatory affairs

Job description

Job Description

Join Our Team as a Regulatory Affairs Specialist!

Job Summary

Are you ready to make a difference in patients' lives? As a Regulatory Affairs Specialist at Pfizer, you will play a crucial role in navigating the regulatory landscape for our innovative products. Under the guidance of experienced leaders, you will conduct strategic regulatory activities to secure and maintain Marketing Authorizations and support Clinical Trial Applications, all while aligning with our business goals and legal requirements.

Your Responsibilities

In this dynamic role, you will:

• Deliver Regulatory Strategy: Advise cross-functional teams to ensure compliance and success.
• Provide Regulatory Advice: Meet customer and cross-divisional requests with expert insights.
• Manage Applications: Oversee New Registration, Marketing Authorization, and Renewal Applications.
• Handle Queries: Address National Regulatory Authority (NRA) queries efficiently.
• Develop Knowledge: Stay updated on NRA expectations to inform regulatory strategies.
• Respond Promptly: Address spontaneous requests from authorities with accuracy.
• Support Clinical Development: Collaborate with national Regulatory Authorities and strategists.
• Maintain Databases: Keep regulatory databases up to date.
• Obtain Approvals: Secure NRA approvals for unlicensed medicines.
• Ensure Compliance: Manage updates to packaging and prescribing information.
• Support Divestments: Assist with MA cancellations and product discontinuations.
• Contribute to Good Regulatory Practice: Uphold high standards in regulatory affairs.
• Lead Personal Development: Take charge of your growth and learning.

What We're Looking For

To thrive in this role, you should have:

• A degree in life sciences or chemistry (honors level or equivalent).
• A Master's degree, Post Graduate Diploma, or PhD is preferred.
• Relevant professional qualifications (e.g., MSc in Regulatory).
• Previous experience in Regulatory Affairs for Human Medicinal Products.
• Strong computer literacy and excellent communication skills.
• A proven ability in analytical thinking.

Note: All applicants must have the relevant authorization to live and work in the UK.

Why Join Pfizer?

• Purpose: At Pfizer, we are driven by our mission to create breakthroughs that change patients' lives. Our values of courage, joy, equity, and excellence guide us in transforming millions of lives.
• Digital Transformation: We are at the forefront of a digital transformation strategy, leveraging new data and automated solutions to enhance drug discovery and development, ultimately improving health outcomes and patient experiences.
• Flexibility: We foster a trusting and flexible workplace culture that promotes work-life harmony, enabling you to be your best self.
• Equal Employment Opportunity: We celebrate diversity and inclusion, recognizing that a varied workforce is essential for our success. Join us in building a culture that empowers all employees.
• DisAbility Confident: As a Disability Confident Employer, we are committed to supporting your application and career journey. We believe in unleashing the power of our people, especially those with unique talents.

Your journey with Pfizer starts here! Together, let's make a difference.