Director Global CMC Strategy Based Anywhere in Europe
Director Global CMC Strategy Based Anywhere in Europe
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Job Description
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; and
Partnership Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes bestinclass iconic brandname 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
The Director Global CMC Strategy is an emerging senior level position recognized as an expert for global CMC regulatory knowledge and quality expertise. The Director will be responsible for providing regulatory guidance and leadership for eyecare products expediting the preparation and review of regulatory submissions in support of Viatris eyecare portfolio. To perform this position successfully an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Every day we rise to the challenge to make a difference and heres how the Director Global CMC Strategy role will make an impact:
To guide develop and execute regional and global regulatory CMC strategies specific to assigned Viatriss eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses.
Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensuring an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership.
Cultivate sustainable and effective relationships across a network of stakeholders partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.
Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation as applicable.
Ensures lifecycle management and maintenance activities including change controls are assessed and executed effectively and efficiently.
Developing and maintaining constructive working relationships with Health Authority lead or participate in meetings with regulatory agencies as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.
Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes systems working practices shared learnings and quality standards.
Understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Using strong experience and examples where appropriate to influence the evolving regulatory environment through Health Authority engagement partners and trade associations.
Supporting regulatory Due Diligence activities for business development opportunities.
Provide input to and adhere to departmental budget.
Performs other duties as assigned.
About Your Skills & Experience
For this role were looking for a candidate who has an effective combination of the following qualifications skills and experiences:
Minimum of a Bachelors degree (or equivalent). A Masters degree (or equivalent) preferred.
Extensive pharmaceutical experience with relevant technical experience (Quality Technical Services R&D) and pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration.
Prior experience managing projects and matrixed teams and/or serving as a people manager.
Global Regulatory Affairs CMC strategy with handon CMC authoring experience (initial registrations or postapproval variations)
High level of knowledge of development & commercial activities and cGMPs to assess technical scientific & regulatory merits of CMC information commitments and data to lead teams and/or complex projects.
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. Knowledge of eyecare products and product development an advantage.
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.
Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt 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
Worklife 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 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 Viatris we offercompetitivesalaries benefitsandan 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.
#LIDNIRequired Experience:
Exec
Employment Type
Full-Time
