Director, Global Regulatory Strategist – Based Anywhere in Europe
Postuler locations Hatfield, England, United Kingdom Zug, Zug, Switzerland Northern Cross, Dublin, Ireland time type Temps plein posted on Offre publiée il y a 18 jours job requisition id R5653294 Generics [U.K.] Ltd. Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. The Role & What You Will Be Doing The Director, Global Regulatory Strategist is an emerging senior level position, recognized as an expert for global regulatory strategy in support of Viatris’ eyecare portfolio. The purpose of this role is to: Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned regional regulatory strategies. Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate. Direct and/or indirect liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitments. Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products. Every day, we rise to the challenge to make a difference and here’s how the Director, Global Regulatory Strategist role will make an impact: Developing Global/Regional regulatory strategies and implementation plans for complex projects/products. Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development. Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products. Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers. Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks are mitigated. Direct activities to ensure the required documentation is prepared to a high standard. Developing and maintaining constructive working relationships with Health Authority contacts. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes. Understanding of current global and regional evolving regulations and guidelines. 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). Extensive in global regulatory experience (US/EU) required. Regulatory Affairs Professional Certification, preferred. Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience. Prior experience managing projects and matrixed teams. Elevated level of knowledge of development & commercial activities. Extensive technical, functional, and industry knowledge. Advanced understanding of current and emerging regulatory requirements & expectations. Proven ability to partner successfully with other functions. 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. 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. 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. Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission.
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Postuler locations Hatfield, England, United Kingdom Zug, Zug, Switzerland Northern Cross, Dublin, Ireland time type Temps plein posted on Offre publiée il y a 18 jours job requisition id R5653294 Generics [U.K.] Ltd. Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. The Role & What You Will Be Doing The Director, Global Regulatory Strategist is an emerging senior level position, recognized as an expert for global regulatory strategy in support of Viatris’ eyecare portfolio. The purpose of this role is to: Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned regional regulatory strategies. Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate. Direct and/or indirect liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitments. Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products. Every day, we rise to the challenge to make a difference and here’s how the Director, Global Regulatory Strategist role will make an impact: Developing Global/Regional regulatory strategies and implementation plans for complex projects/products. Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development. Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products. Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers. Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks are mitigated. Direct activities to ensure the required documentation is prepared to a high standard. Developing and maintaining constructive working relationships with Health Authority contacts. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes. Understanding of current global and regional evolving regulations and guidelines. 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). Extensive in global regulatory experience (US/EU) required. Regulatory Affairs Professional Certification, preferred. Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience. Prior experience managing projects and matrixed teams. Elevated level of knowledge of development & commercial activities. Extensive technical, functional, and industry knowledge. Advanced understanding of current and emerging regulatory requirements & expectations. Proven ability to partner successfully with other functions. 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. 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. 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. Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission.
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