Director, Regulatory Strategist

🔥 0 minutes ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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Viatris

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Healthcare • Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Provide strategic regulatory guidance using innovative regulatory approaches for assigned projects/products • Develop and implement global regulatory strategies for complex products/projects • Manage preparation and submission of correspondence and applications to regulatory agencies • Organize, lead, or participate in meetings with regulatory agencies • Ensure quality expectations are met for submissions and Health Authority interactions • Direct and/or facilitate communications with Health Authorities alongside regulatory local/regional partners • Lead global Regulatory Teams for assigned projects/products • Develop global/regional regulatory strategies and implementation plans • Partner with cross-functional project teams as Regulatory Point of Contact • Partner with clinical, safety, and medical teams on product development and maintenance activities • Contribute to Target Product Label and CCDS development and updates • Drive regulatory contributions and submission packages, including meeting requests, dossier sections, and query responses • Monitor regulatory plans, communicate progress to senior leadership, and mitigate risks • Build working relationships with Health Authority contacts • Support regulatory due diligence for business development opportunities • Assess evolving global and regional regulations and their impact on products/projects • Ensure regulatory requirements and commitments are met for Marketing Authorizations • Implement regulatory standards, systems, processes, and productivity improvements

🎯 Requirements

• 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 managing global and/or regional regulatory and registration activities in drug development and/or post-marketing lifecycle management • Ability to manage complex regulatory issues • Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable • 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 • Proven track record negotiating with major Health Authorities, 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 • Strong track record demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role with minimal supervision • Advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or business qualification (DMS, MBA) may be an advantage but is not essential

🏖️ Benefits

• Competitive salaries • Benefits • Inclusive environment • Equal opportunity employment

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