Director, Regulatory Strategist
Level inferred from job title
Job description
A senior Director, Global Regulatory Strategist role at Viatris, responsible for developing and implementing global regulatory strategies for complex products and leading interactions with Health Authorities. The position supports the company's innovative and established originator product portfolio.
At a glance
- Work mode
- Remote
What you'll do
- Developing Global/Regional regulatory strategies and implementation plans for complex projects/products including novel, product enhancement, post approval and established products
- Leading the Global Regulatory sub-team and partnering with cross functional project teams as the Regulatory Point of contact for assigned products
- Partnering with clinical, safety and medical for critical activities supporting product development and maintenance including regulatory input to clinical development programs, PMCs/PMRs, PASS, PAES, risk/benefit assessments, RMPs, PSURs
- Serving as a member of the Product Labelling Team, contributing to the development and update of the Target Product Label and CCDS
- Providing strategic regulatory expertise in label negotiations for products assigned during registration and maintenance, including local and regional labels
- Driving development of key Regulatory contributions and fit for purpose submission packages in collaboration with partner lines
- Authoring regulatory contributions such as meeting requests, sections of the dossier, query responses
- 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
- Organizing, leading or participating in meetings with regulatory agencies
- Supporting regulatory Due Diligence activities for business development opportunities
- 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
What we're looking for
- B.S. Scientific Degree required
- Relevant Global and/or Regional regulatory experience
- Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
- Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including ability to manage complex regulatory issues
- Proven ability to deliver to time, cost, and quality standards
- Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other cross functional partners and senior stakeholders to achieve objectives
- Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans
- Proven ability to deliver in a highly matrixed organization
- Strong written and verbal communication skills
Nice to have
- 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
- Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable
- Desirable experience would include a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision
Your team
Global Regulatory
Benefits
An inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others
- Competitive salaries
- Benefits
Apply
About Viatris
A global healthcare company uniquely positioned to bridge the traditional divide between generics and brands
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. 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.
Mission
To empower people worldwide to live healthier at every stage of life
Key facts
- Healthcare
- Supplies high-quality medicines to approximately 1 billion patients around the world annually
- Included on a number of award lists