Senior Regulatory Associate
About this opportunity
JOB SUMMARY
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.
JOB RESPONSIBILITIES
Deliver Regulatory Strategy and Advise Cross-Functional Teams
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
Manage New Registration/Marketing Authorization Applications
Manage Marketing Authorization (MA) Variation Applications
Manage MA Renewal Applications
Management of NRA queries
Develop knowledge of NRA’s expectations, ways of working etc. to 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.
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) in UK & Ireland
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. Let’s start the conversation!
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!
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
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 119 comparable Senior Regulatory Affairs roles across 42 biopharma companies.
Salary context
35 of 119 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 119 comparable roles
+ 21 more countries
Seniority mix
119 of 119 peers have a known seniority level
Therapeutic area mix
17 of 119 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.