Sr. Principal Scientist (Sr. Director) - Regulatory Liaison

MSD • Rockville, MD

1d • $190,800 - $300,300 • Hybrid

About The Position

The Senior Principal Scientist, Regulatory Affairs Liaison develops and implements worldwide regulatory strategy for General Medicine programs, with a focus on cardiovascular metabolic development. Working with a high degree of independence, this leader provides strategic regulatory oversight to optimize labeling and support the shortest time to approval. The role manages assigned programs as Global Regulatory Lead (GRL), serving as the accountable global regulatory point of contact for project teams and interacting with global health authorities and subsidiaries on registration requirements for investigational and marketed drugs or biologics across early- and late-stage development. Programs may involve multiple indications, formulations, or external business partners. The role may also include periodic non-program assignments in General Medicine.

The position leads global regulatory strategy and cross-functional regulatory support throughout product development and the marketed-product lifecycle. It advises development teams, coordinates regulatory engagement across regions, reviews and approves regulatory documents and study protocols, and represents the company in interactions with the FDA and internal committees. The role reports to an Executive Director or Associate Vice President, General Medicine.

The primary location is Rahway, New Jersey, with a hybrid work arrangement. Travel requirements are 10%. The position is regular, offers domestic relocation, and does not offer visa sponsorship. The stated salary range for the primary location is $190,800–$300,300, with eligibility for an annual bonus and long-term incentive, if applicable.

Requirements

• Degree in biological science or a related discipline.
• With a B.S. or M.S.: at least 10 years of relevant drug development experience, with the majority in regulatory affairs.
• With an M.D.: at least 7 years of relevant drug development experience, including 5 years in regulatory affairs.
• With a Ph.D. or Pharm.D.: at least 7 years of relevant drug development experience, including 5 years in regulatory affairs.
• Ability to achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead.
• Outstanding interpersonal, verbal and written communication, and negotiation skills.
• Demonstrated leadership attributes, including experience building and leading high-performing teams.
• Skills listed include biological sciences, clinical reporting, drug development, global health, in vitro diagnostics, multiple therapeutic areas, pharmaceutical regulatory affairs, process improvements, product approvals, regulatory affairs compliance and management, regulatory communications, regulatory compliance and issues, regulatory strategies and strategy development, and written communication.

Nice To Haves

• Substantial experience with cardiovascular, renal, or respiratory development programs, including pediatric, orphan drug, and expedited development programs.
• Substantial experience with both small- and large-molecule development programs.
• Global regulatory affairs experience in markets such as the EU, China, and Japan.
• Prior Global Regulatory Lead oversight of global regulatory submissions and approvals, including INDs/CTAs and NDAs/BLAs.
• Knowledge and experience with devices such as inhalers, auto injectors, and pre-filled syringes.
• Proficiency in AI applications such as Co-pilot and ChatGPT.

Responsibilities

• Oversee development and execution of global regulatory strategy for assigned cardiovascular metabolic programs, optimizing labeling and supporting timely approvals across multiple indications.
• Serve as Global Regulatory Lead and regulatory point of contact for Early Development Teams and Product Development Teams, advising on regulatory issues throughout the lifecycle of development and marketed products.
• Lead Global Regulatory Teams for assigned cardiovascular, renal, and respiratory programs, coordinating global cross-functional regulatory support.
• Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Communicate directly with the FDA, chair company-FDA meetings, and prepare company teams for meetings with the agency at any phase of drug development.
• Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, Regulatory Affairs International, and subsidiary registration departments, providing strategic direction across regions.
• Review and provide final approval of worldwide marketing applications, clinical study reports, protocols, and investigator brochures before external release.
• Represent Global Regulatory Affairs on internal committees and provide regulatory advice and approvals according to committee charters, including Document Review Committees, PDT, EDT, and label development teams.
• Conduct initial IND/CSA content review and approval to facilitate agency approval to conduct clinical trials.
• Participate in regulatory due diligence for licensing candidate review.
• Undertake periodic non-program assignments in General Medicine as needed.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior