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Director, Technical Advocacy and Policy, Regulatory Affairs - Global

Dublin, Ireland; London, United Kingdom; Haarlem, Netherlands; Carlow, Ireland; Dunboyne, Ireland; São Paulo, Brazil

Job Description

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/7/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date: 06/07/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID: R294617

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