At a Glance
- Tasks: Lead global regulatory strategies for innovative healthcare products and ensure compliance with health authorities.
- Company: Viatris, a global healthcare leader bridging generics and brands.
- Benefits: Competitive salary, inclusive culture, and opportunities to make a real impact.
- Other info: Join a dynamic team dedicated to empowering healthier lives worldwide.
- Why this job: Shape the future of healthcare by influencing regulatory strategies and improving patient access.
- Qualifications: Scientific degree required; advanced degrees and regulatory experience preferred.
The predicted salary is between 63000 - 77000 £ per year.
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually.
The Director, Global Regulatory Strategist is a senior level position, recognized as an expert for global regulatory strategy in support of Viatris' innovative and established originator product portfolio.
Purpose of this role:
- Provide strategic regulatory guidance using innovative regulatory approaches for assigned projects/products.
- Develop and implement Global regulatory strategies for complex products/projects, integrating inputs from regulatory team and cross functional partners.
- Manage the preparation and submission of correspondence and applications to regulatory agencies.
- Organize, lead or participate in meetings with regulatory agencies, as appropriate.
- Ensure quality expectations are met for all submissions and Health Authority interactions.
- Lead global Regulatory Teams for assigned projects/products.
Key responsibilities for this role include:
- Developing Global/Regional regulatory strategies and implementation plans for complex projects/products.
- Leading the Global Regulatory sub-team and partnering with cross functional project teams as the Regulatory Point of contact for assigned products.
- Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products.
- Partnering with clinical, safety and medical for critical activities supporting product development and maintenance.
- Serving as a member of the Product Labelling Team, contributing to the development and update of the Target Product Label and CCDS.
- Driving development of key Regulatory contributions and fit for purpose submission packages in collaboration with partner lines.
- Ensuring regulatory plans are monitored, progress is communicated to Senior leadership and any risks are clearly communicated and mitigated where possible.
- Developing and maintaining constructive working relationships with Health Authority contacts.
Business and Industry Leadership:
- Supporting regulatory Due Diligence activities for business development opportunities.
- Enhanced understanding of current global and regional evolving regulations and guidelines.
- Using strong experience and examples to influence the evolving regulatory environment through Health Authority engagement.
Governance and Compliance:
- Ensuring all regulatory requirements and/or commitments are met for obtaining and maintaining Marketing Authorizations.
- Ensuring business compliance and implementation of and adherence to regulatory standards.
- Implementing systems, processes and procedures relating to regulatory productivity improvements.
The minimum qualifications for this role are:
- B.S. Scientific Degree required.
- An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
- Relevant Global and/or Regional regulatory experience.
- Proven experience in managing global and/or regional regulatory and registration activities.
- Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
- Proven ability to deliver to time, cost, and quality standards.
- Strong written and verbal communication skills.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer.
Director, Regulatory Strategist in Kent employer: Viatris
Viatris UK Healthcare is an exceptional employer that empowers its employees to make a meaningful impact on global health. With a collaborative culture that fosters personal growth and resilience, the company offers extensive opportunities for professional development in the dynamic field of digital marketing. Located in the UK, Viatris not only provides competitive benefits but also encourages innovation and creativity, making it a rewarding place to work for those passionate about improving healthcare outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Strategist in Kent
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Viatris. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
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 Viatris.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Viatris. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Viatris is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director, Regulatory Strategist in Kent
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 Viatris!
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 Viatris 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 Viatris!
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 Viatris, 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 Viatris
✨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 Viatris 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 Viatris’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.
