Job Details

Global Regulatory Liaison

The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Immunology therapeutic area. Acting as the single, accountable global point of contact, with significant experience, theLiaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This position requires an experienced leader who is proactive, self-motivated and who can independently manage complex programs that may involve multiple indications, formulations, or external partners. The Liaison engages directly with global regulatory authorities to ensure successful registration and compliance. Global Immunology submission experience in IBD strongly preferred.

Primary Responsibilities include:

• Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals.
• Serve as an experienced worldwide regulatory representative on Asset or Product Development Teams and act as the regulatory single point-of-contact for assigned products across GRACS and external partners.
• Provide expert regulatory guidance to cross-functional development teams and regional subsidiaries throughout the product life cycle.
• Oversee and independently lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation.
• Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications.
• Lead cross-functional teams in preparation for regulatory advisory committee meetings and may include a speaking role.
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Provide final regulatory review and approval of: worldwide marketing applications, clinical study protocols and reports, investigator brochures, local registration study protocols for secondary markets.
• Represent Global Regulatory Affairs on internal committees (e.g., DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals.
• Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation.
• Participate in regulatory due diligence activities for in-licensing opportunities.

Education Requirements include:

• B.S. or M.S. in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience.
• M.D. or Ph.D./Pharm D with 7+ years of experience.

Required Experience and Skills include:

• Proven ability to operate independently with minimal direction and deliver results.
• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective communicatorboth written and verbalwith the ability to influence, lead, and negotiate across levels and functions.
• Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA).
• Demonstrated expertise in leading regulatory filings across global regions.

Preferred Experience and Skills include:

• Therapeutic area expertise in Immunology.
• Experience with biologics or small molecules.
• Substantial experience in US & International Regulatory Affairs with prior experience as a Global Regulatory Lead.
• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.
• Outstanding interpersonal, communication and negotiation skills.
• Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
• Prior people management experience.

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.