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For Companies At a Glance
- Tasks: Lead regulatory strategies for respiratory products and collaborate with global stakeholders.
- Company: Viatris, a forward-thinking pharma company dedicated to improving global health.
- Benefits: Competitive salary, inclusive culture, career progression, and work-life balance.
- Why this job: Make a real impact in healthcare while advancing your career in a supportive environment.
- Qualifications: Experience in CMC authoring and regulatory for respiratory products is essential.
- Other info: Join a diverse team committed to sustainability and community health.
The predicted salary is between 48000 - 72000 £ 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.
We do so via:
- Access – Providing high quality trusted medicines regardless of geography or circumstance.
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health.
- 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; 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
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. Monitor the external competitor and regulatory environment and build knowledge into project strategies. Performs other duties or equivalent duties for other product types as assigned. Serves as the primary reviewer of global CMC strategic plans and documentation/submissions for the assigned products (primarily within the respiratory product portfolio).
About Your Skills & Experience
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. Advanced skills in written & oral communications (mandatory). 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.
Why 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. 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.
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.
Viatris is an Equal Opportunity Employer.
Director Respiratory Regulatory CMC employer: Viatris
Contact Detail:
Viatris Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Respiratory Regulatory CMC
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Viatris or similar companies. A friendly chat can open doors and give you insights that might just help you land that Director role.
✨Tip Number 2
Prepare for interviews by diving deep into Viatris' values and mission. Show us how your experience aligns with our commitment to healthcare and innovation. We love candidates who are passionate about making a difference!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email. It shows your enthusiasm and keeps you fresh in our minds as we make decisions.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the Viatris family. Let’s make healthcare better together!
We think you need these skills to ace Director Respiratory Regulatory CMC
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director Respiratory Regulatory CMC role. Highlight your hands-on CMC authoring experience and any specific knowledge you have in respiratory/inhaled products. We want to see how your skills align with what we’re looking for!
Showcase Your Communication Skills: Since advanced written and oral communication skills are a must, don’t shy away from demonstrating these in your application. Use clear, concise language and make sure your documents are well-structured. This is your chance to show us how you can effectively communicate complex regulatory information.
Highlight Relevant Experience: Be sure to emphasise your experience managing projects and working with cross-functional teams. We’re looking for someone who can lead and contribute significantly to our respiratory portfolio, so share examples of how you’ve done this in the past!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us that you’re genuinely interested in joining our team at Viatris!
How to prepare for a job interview at Viatris
✨Know Your CMC Inside Out
Make sure you brush up on your hands-on CMC authoring experience, especially for respiratory and inhaled products. Be ready to discuss specific examples of your work in regulatory submissions and how you've navigated complex projects.
✨Showcase Your Strategic Thinking
Prepare to demonstrate your ability to integrate strategies into actionable plans. Think about past experiences where you shaped project strategy or reduced regulatory burdens, and be ready to share those insights during the interview.
✨Engage with Regulatory Knowledge
Familiarise yourself with current and emerging regulatory requirements. Be prepared to discuss how you've interacted with regulatory authorities in the past and how you can leverage that experience to benefit the company.
✨Highlight Your Collaborative Spirit
Viatris values collaboration across various functions. Think of examples where you've successfully partnered with teams like Quality, Safety, or Commercial to achieve objectives, and be ready to share how you can bring that collaborative mindset to the role.
