MSD Director Technical Advocacy Policy Regulatory Affairs - Global 

Ireland 

406067647

In this role, you willbe responsible for

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,identifyingpotential 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 toanticipatehow policies mayimpactthe organization.

• Excellent collaboration skills, working effectively with diverse functions and perspectives toestablishan 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.

• Experiencerepresentingcompanies in trade associations and industry forums, contributing to industry-widepositionsand influencing policy outcomes.

Benefits of the position:

• internationally-focusedteams.

• 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.