At a Glance
- Tasks: Lead regulatory strategies and manage compliance for innovative respiratory products.
- Company: Join Viatris, a global leader in healthcare committed to making a difference.
- Benefits: Enjoy competitive pay, great benefits, and a supportive work-life balance.
- Other info: Diversity and inclusion are at the heart of our mission; all backgrounds are welcome.
- Why this job: Make a real impact on global health while advancing your career in a dynamic environment.
- Qualifications: Experience in Regulatory CMC for respiratory products and strong project management skills.
The predicted salary is between 65250 - 79750 £ per year.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life.
Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and Partnership - Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience.
The Role & What You Will Be Doing:
- Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
- Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.
- Guides preparation of CMC submission documentation where assigned.
- Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.
- Responsibilities include the lead in preparations and interactions for regulatory authority meetings.
- Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross-functional project teams.
- Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
- Monitors the external competitor and regulatory environment and builds knowledge into project strategies.
Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations).
Mandatory hands-on experience in Regulatory CMC for respiratory/inhaled products.
High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects. Specific knowledge in development and life cycle management of respiratory/inhaled products is highly preferred.
Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas.
Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Specific knowledge in development of respiratory/inhaled products or other combination product types with similar complexity is highly preferred.
Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.
Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.
Computer literacy with Microsoft Office Suite and Documentum-based applications.
Prior experience managing projects and matrixed teams and/or serving as a people manager.
Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.
Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
Ability to engage in the external regulatory and pharmaceutical environment.
Proven ability to deliver to time, cost and quality standards.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Demonstrated experience serving as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains including respiratory products.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply.
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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris:
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.
Regulatory Affairs Manager Healthcare in Hatfield employer: Viatris
Viatris is an exceptional employer that prioritises employee well-being and professional growth, offering a competitive compensation package alongside hybrid work options in the vibrant setting of Hatfield, UK. With a strong focus on collaboration and innovation, employees are encouraged to develop their skills and advance their careers within a supportive work culture that values diversity and inclusion.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager Healthcare in Hatfield
✨Unlock Networking Opportunities
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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 Viatris.
✨Leverage Internships for Full-time Roles
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We think you need these skills to ace Regulatory Affairs Manager Healthcare in Hatfield
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.
