Director Global CMC Strategy – Based Anywhere in EuropeSolicitar locations: Hatfield, England, United Kingdom; Zug, Zug, Switzerland; Northern Cross, Dublin, Ireland
Time type: Tiempo completo
Posted on: Publicado hace 2 días
Job requisition id: R5653293
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 here's how the Director Global CMC Strategy role will make an impact:
Guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris's 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. Ensure 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.Ensure lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently.Develop and maintain constructive working relationships with Health Authority contacts. Organize, 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.Understand current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Use strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.Support regulatory Due Diligence activities for business development opportunities.Provide input to and adhere to departmental budget.Perform other duties as assigned.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:
Minimum of a Bachelor's degree (or equivalent). A Master's 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 hands-on CMC authoring experience (initial registrations or post-approval variations).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.Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas.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 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:
Excellent career progression opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & 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.
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