Director, Regulatory Strategy

About Us

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A leading global pharmaceutical company, [Company Name] is dedicated to improving lives by developing and delivering innovative pharmaceuticals. Our focus is on creating value for patients, customers, and investors by combining the resources, scale, and diversity of a global organization with the agility and entrepreneurial spirit of a smaller company.

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Job Summary

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We are seeking an experienced director to lead our Regulatory Strategy team. You will be responsible for developing and implementing global regulatory strategies for our pharmaceutical products. This includes providing strategic guidance and oversight to cross-functional teams, collaborating with stakeholders across the organization, and interacting with regulatory authorities.

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Key Responsibilities

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• Develop and implement global regulatory strategies for pharmaceutical products, ensuring alignment with business objectives and compliance with regulatory requirements.

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• Provide strategic guidance and oversight to cross-functional teams, including Regulatory Affairs, R&D, Manufacturing, and Marketing.

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• Collaborate with stakeholders across the organization, including senior leadership, to ensure effective implementation of regulatory strategies.

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• Interact with regulatory authorities, including the FDA, EMA, and other regional authorities, to ensure successful outcomes for regulatory submissions.

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• Stay up-to-date with evolving regulatory requirements and emerging trends, and adjust regulatory strategies accordingly.

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• Partner with external experts and consultants as necessary to provide additional regulatory expertise.

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• Manage and direct a team of regulatory professionals, providing guidance, coaching, and development opportunities.

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Requirements

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• Advanced degree in a life science or related field (MS, Ph.D., PharmD).

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• Minimum 10 years of experience in regulatory affairs, with at least 5 years in a leadership role.

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• Proven track record of success in developing and implementing global regulatory strategies for pharmaceutical products.

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• Strong knowledge of global regulatory requirements, including FDA, EMA, and other regional authorities.

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• Excellent communication, leadership, and project management skills.

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• Ability to work effectively in a fast-paced environment and adapt to changing priorities.

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What We Offer

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• Competitive salary and benefits package.

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• Opportunity to work on innovative pharmaceutical products that improve patient lives.

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• Collaborative and dynamic work environment.

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• Professional development opportunities.

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How to Apply

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If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application, including your resume and a cover letter, to jobs@company.com.