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)
- Computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
Work Location Assignment: Hybrid (some office presence is required)
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!
Regulatory Affairs