At a Glance
- Tasks: Lead regulatory strategies to ensure life-saving treatments reach patients faster.
- Company: Join Pfizer, a leader in global health and innovation.
- Benefits: Enjoy a hybrid work model, competitive salary, and a culture of flexibility.
- Other info: Be part of a diverse team committed to excellence and patient-centric solutions.
- Why this job: Make a real impact on global health while developing your career in a dynamic environment.
- Qualifications: Scientific degree with experience in regulatory processes and drug development.
The predicted salary is between 42750 - 52250 £ per year.
Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity.
Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines.
Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail.
Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.
What You Will Achieve
The primary purpose & key accountabilities of the role
- Represent Rest of World (ROW) region for regulatory sciences.
- Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
- Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
- Accountable for timely submissions and approvals with commercially attractive labeling in the designated region
- Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
The primary responsibilities critical to the role are
- Accountable for ensuring regional (ROW) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
- Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities.
- Partners with project teams and other customer groups to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
- Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
- Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.
- Engages in appropriate activities in order to influence the regional regulatory environment through Oncology GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
- Ensures business compliance and implementation of and adherence to Regulatory standards.
- Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.
- Here Is What You Need (Minimum Requirements)
- Scientific Degree. A higher degree may be an advantage but is not essential.
- Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
- Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.
Equivalent experience, either at a regulatory agency or working on substantive industry -government collaborations, can be considered.
- Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
- Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines.
Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs.
Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations.
- Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
- Presentation skills - Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, direct reports and senior manager.
- Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups.
Can be direct and forceful as well as diplomatic.
Gains trust quickly of other parties to the negotiations.
- ORGANIZATIONAL RELATIONSHIPS
- Reports to ROW Regulatory Strategy Lead, Oncology
- Works with GRS colleagues and relevant project team(s)members (i. e.
Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).
- Partners with regional colleagues, including GRS-in Country colleagues, Medical and Commercial colleagues, to provide a regional position.
- Works directly or indirectly with external contacts in Regulatory Agencies within assigned region, as well as relevant experts and key opinion leaders.
- Ensures alignment with Global Regulatory Lead and Global Regulatory Portfolio Lead.
Work Location Assignment
- Hybrid
- 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.
Dis Ability 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.
Manager, Oncology Regulatory Strategy in Tadworth employer: Pfizer
Pfizer is an exceptional employer, offering a dynamic and inclusive work culture that prioritises innovation and collaboration. As a leader in the healthcare industry, employees benefit from extensive growth opportunities, competitive compensation, and a comprehensive benefits package, including health coverage and retirement plans. The hybrid work model allows for flexibility while working on impactful projects that shape the future of clinician engagement globally.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Oncology Regulatory Strategy in Tadworth
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Pfizer. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Pfizer.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Pfizer. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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We think you need these skills to ace Manager, Oncology Regulatory Strategy in Tadworth
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Pfizer!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Pfizer that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Pfizer!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Pfizer, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Pfizer
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Pfizer that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Pfizer’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
