Executive Director, EMEA Regional Regulatory Operations

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs teams bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Executive Director, EMEA Regional Regulatory Operations will manage a large team of regulatory professionals and oversee all the Regulatory Operations activities in order to deliver high-quality, timely regulatory submissions across the regulatory portfolio.

What you will do:

• You will be responsible for driving the strategic direction of the group and manage a department of colleagues to meet the current and anticipated business needs.
• You will have a scope of circa 120 countries with complex and evolving regulatory requirements by jurisdiction.
• You will drive the continued advancement and maturity of regional planning and publishing capabilities as well as the continuous improvement of business process and technology to meet stakeholder needs while adapting to a fast-paced regulatory environment.
• You will be accountable for submissions planning and subsequent submission to Health Authorities within the Region and serve as a critical partner with Regional Regulatory Teams (Regulatory Affairs International Leadership at Regional and Country levels) for meeting business objectives.
• You will be part of the EMEA Regulatory Affairs Leadership team.
• You will serve as a contributor to broader Innovation, Quality, & Strategic Execution (IQSE) organisational goals.
• You will work in partnership with HQ/Global teams in the execution of functional capabilities (planning, publishing, business process management, and information management).
• You will liaise externally with counterparts in industry and industry working groups to contribute to regional and global level advancement of policy objectives impacting regulatory operations activities (submissions planning and publishing domains as well as regulatory information management).

What qualifications, skills and experience you need:

• Bachelor’s degree in a scientific discipline required
• Minimum of 10-12 years’ experience in Regulatory Affairs (with at least 3 years’ experience within Regulatory Operations activities (regulatory project management, regulatory business operations, submissions planning, submissions publishing, regulatory information management, etc)
• Regulatory Knowledge & Experience: Deep understanding of regulatory submissions procedures and drug development landscape across the Region
• Understanding of the regulatory operations aspects to effectively represent regulatory operations in Regional activities and on the Regional Regulatory Affairs Leadership team.
• Significant people leadership experience (attract, develop, and retain employees, cultivate a high performing team climate that continuously strives to deliver organisational value & impact, mentoring and coaching).
• Fluent in English (written & spoken)

Desired Experience and Skills:

• Expert in project management methodologies (e.g. PMP, Sigma, Change Management, etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
• Region-specific regulatory knowledge (RAPS certification or in-region experience)
• Advanced degree preferred (engineering or scientific discipline, MBA)

Ways of Working/Competencies:

• Silos to networks: collaboration and building partnerships with internal and external stakeholders
• Planning to experimentation: process improvement and decision making
• Withholding to sharing strong interpersonal and communication skills
• Knowing to learning ability to learn new concepts and adapt to new ways of working

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R143293