Department

Global Regulatory Policy

Brief Description of Position

The Global Regulatory Policy (GRP) team advocates for regulatory policy that supports our company\xe2\x80\x99s business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical leader. We work in partnership with the Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a prioritized plan for policy that advances business goals. Our GRP team responsibilities include:

• Developing and delivering world-class regulatory policy service for all business segments and regions.
• Proposing - and responding to - regulatory guidance and action.
• Advocating for and anticipating regulatory change with globally leading regulators and multilateral organizations.
• Providing insights and advocating for positions on critical regulatory issues and trends.
• Building our company\xe2\x80\x99s share of voice and influence extramurally to support the enterprise policy agenda.

Responsibilities and activities of the Director, EEMEA Lead, Regional Regulatory Policy:

• Serving as subject matter expert in regulatory processes, laws, and regulations, for assigned areas, with a working knowledge of how regulatory policy is shaped and developed in the EEMEA region
• Proactively monitoring emerging scientific and regulatory trends/strategies, both internally and externally, to shape and influence changes in the global regulatory environment.
• Monitoring emerging regulatory policy issues in assigned areas, including issues arising from regional regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identifying those issues likely to impact the company\xe2\x80\x99s regulatory strategy or product portfolio.
• Providing insights and advocating for positions on critical regulatory issues and trends to Research and Development business partners and to contribute to a broader policy platform, working closely with public policy colleagues.
• Building and sharing our company\xe2\x80\x99s share of voice and influence extramurally to support the enterprise policy agenda through engagement in trade associations and representation for industry initiatives that support the region
• Defining and delivering elements within a wider regional regulatory policy plan that address current and future business needs that is co-designed with GRACS regional leadership and in partnership with our company\xe2\x80\x99s policy teams at the global, regional, and country levels
• Proposing - and responding to \xe2\x80\x93 draft regulatory guidance and policy action at the regional/group level and support to country teams for national guidance.
• Participating in industry and professional meetings in assigned areas to actively advocate for company-specific or Industry-wide issues.
• Advocating for and anticipating regulatory change with EEMEA-based globally leading regulators and EEMEA-focused multilateral organizations.
• Coordinating appropriate internal staff to develop company responses to draft legislation, regulations, guidance, and other regulatory policy documents.
• Leading internal teams as assigned to address regulatory policy issues. Assignments will evolve over time to meet programmatic needs.
• Planning and managing interactions and communications with trade associations and health authorities on regulatory policy matters.
• Participating in industry and professional meetings to maintain competency on regulatory policy issues.

Extent of Travel

Up to 30% on an Annualized Basis

Qualifications, Skills & Experience

• Experience in policy development and advocacy, preferably in pharmaceuticals, and a strong understanding of regulatory affairs and healthcare systems.
• Experience in European regulatory settings preferred.
• Strong communication skills and leadership abilities for strategic action demonstrated in previous roles.

Educational qualifications:

• Bachelor of Science is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a post-graduate degree in science, health care, public health, health policy, or law

Required experience:

• At least 8 years relevant working experience with a regulator or other health authority, within industry in regulatory affairs, or other relevant biopharmaceutical policy role;
• Strong interpersonal, writing and communication skills with ability to demonstrate analytic thinking, excellent presentation and negotiation skills
• Ability to fully demonstrate leadership principles, specifically collaboration, driving results and building talent.
• Ability to thrive in a cross-functional team environment with a global mindset
• Flexibility for travel
• Excellent command of English and another European language (written and spoken).

Preferred experience:

• Master\xe2\x80\x99s degree or PhD in science, health care, public health, health policy, or law
• Experience in working in the field of quality control or medicines development.

Current Employees apply

Current Contingent Workers apply

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: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Specified

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): No

Merck & Co.