At a Glance
- Tasks: Lead global regulatory strategies for complex pharmaceutical products and ensure successful submissions.
- Company: Viatris, a global healthcare leader committed to empowering healthier lives.
- Benefits: Competitive salary, career progression, work-life balance, health insurance, and bonus scheme.
- Other info: Join a diverse team dedicated to redefining healthcare and making a difference.
- Why this job: Make a real impact in healthcare while developing your skills in a collaborative environment.
- Qualifications: Bachelor's degree in science; experience in regulatory affairs and CMC required.
The predicted salary is between 63000 - 77000 £ per year.
Mc Dermott Laboratories Limited 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 and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
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.
Viatris is more than just a place to work.
This is a place to make a difference in the world.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Regulatory Science CMC Complex role will make an impact:
- Develop and execute global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management activities.
- Independently assess CMC regulatory requirements, identify potential risks, and develop mitigation strategies to support successful regulatory outcomes.
- Prepare, coordinate, and deliver high-quality global CMC regulatory submissions, including new registrations, post-approval changes, renewals, annual reports, and line extensions.
- Support Global Regulatory Leads or act as the Global Regulatory Lead for assigned products and major regulatory projects.
- Serve as the CMC regulatory representative on cross-functional project teams, partnering closely with R&D, Quality, Regulatory Affairs, Technical Operations, and regional stakeholders.
- Manage regulatory commitments, submission timelines, agency interactions, and regulatory intelligence activities with minimal supervision.
- Lead responses to health authority questions and provide quality review of complex regulatory submissions.
- Act as a scientific and technical subject matter expert, providing guidance, mentorship, and regulatory leadership to colleagues and project teams.
- Contribute to regulatory process improvements, strategic initiatives, and high-priority business projects that support the global complex products portfolio.
- Build and maintain effective relationships with regulatory authorities and internal stakeholders to enhance regulatory success.
About Your Skills & Experience
For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
- Bachelor's degree in a scientific discipline required; Master's degree preferred.
- Significant pharmaceutical industry experience, including regulatory affairs experience within CMC.
- Hands-on experience authoring CMC regulatory submissions for new registrations and/or post-approval variations.
- Strong understanding of pharmaceutical development, manufacturing processes, c GMP requirements, and lifecycle management.
- Experience supporting complex dosage forms such as drug-device combinations, injectable products, respiratory products, creams, or ointments is highly desirable.
- Advanced knowledge of global regulatory requirements, submission pathways, and regulatory expectations.
- Experience supporting submissions such as NDA, ANDA, supplements, amendments, DMFs, and comparable European procedures is preferred.
- Ability to interpret and apply global and regional CMC guidelines while contributing to regulatory strategy development.
- Excellent written and verbal communication skills with the ability to communicate effectively across all levels of an organization.
- Demonstrated project management skills and ability to manage multiple priorities in a fast-paced, global environment.
- Strong business acumen, problem-solving capabilities, and sound scientific judgment.
- Proficiency with Microsoft Office applications and regulatory document management systems.
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.
You may just be the right candidate for this or other roles.
Benefits At Viatris
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.
- Some of our benefits include the following on top of a competitive salary:
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
- 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.
If you would like to know more about what diversity, equity and inclusion means to us, please visit
Sustainability at Viatris
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.
To learn more about our efforts, please visit
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.
Senior Manager, Regulatory Science CMC Complex 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 Senior Manager, Regulatory Science CMC Complex
✨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 Senior Manager, Regulatory Science CMC Complex
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.
