Director, Technical Advocacy and Policy, Regulatory Affairs - Global

Join our team as the Director of Technical Advocacy and Policy in the Regulatory Chemistry, Manufacturing, and Controls (CMC) department.

In this role, you will be responsible for managing policy review, coordinating company positions, and influencing the global regulatory environment. We are seeking a proactive professional with experience authoring or reviewing regulatory submissions,  excellent collaboration and communication skills, and a passion for driving policy and advocacy initiatives.

Key Responsibilities:

• Oversee international policy review process within the CMC department, ensuring thorough analysis and understanding of evolving regulatory policies and guidelines.

• Collaborate with cross-functional teams and stakeholders to derive aligned company positions on policy matters, considering multiple perspectives, including international considerations.

• Synthesize complex regulatory information into clear recommendations, keeping colleagues well-informed about relevant policy developments, particularly on the international stage.

• Develop advocacy strategies to influence the external regulatory environment domestically and internationally, aligning with company goals and recognizing opportunities to share messaging.

• Stay updated on regulatory trends, changes, and emerging issues primarily at international levels, identifying potential challenges and opportunities.

• Articulate the company's technical and policy position to internal stakeholders and external trade associations, advocating for the company's interests and fostering strategic relationships.

• Represent the company at external forums and trade association meetings, ensuring company positions are heard and bringing back pertinent information.

• Establish strong relationships and trust across the TAP Network to enhance communication and collaboration.

Education and Experience Minimum Requirements:

• B.S./B.A. in a science or technology-related field with a minimum of 10 years' experience in the pharmaceutical industry or regulatory agency.

Preferred Experience and Skills:

• Substantial experience in regulatory affairs.

• Forward-thinking mindset with the ability to anticipate how policies may impact the organization.

• Excellent collaboration skills, working effectively with diverse functions and perspectives to establish an aligned company position.

• Strong analytical and synthesizing skills, distilling complex information into concise insights with a global perspective.

• Working knowledge of international regulatory frameworks, standards, and processes in CMC.

• Ability to confidently share perspectives on policy matters, advocating for the organization's interests.

• In-depth knowledge of CMC and Quality regulatory requirements and processes, enabling effective engagement on technical advocacy and policy matters.

• Experience representing companies in trade associations and industry forums, contributing to industry-wide positions and influencing policy outcomes.

Benefits of the position:

• Make valuable connections across the company, collaborating with colleagues from various departments and internationally-focused teams.

• Shape the global regulatory environment and contribute to improved healthcare worldwide.

• Gain exposure to the evolving international regulatory landscape, offering ongoing professional development and learning opportunities.

If you are a proactive professional with a strong background in regulatory affairs, specifically within CMC, and are passionate about driving policy and advocacy initiatives on national and international levels, we encourage you to apply for this rewarding position.