Senior Director (Sr Principal Scientist), Regulatory Liaison

Job Description

The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate Vice President, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects in the General Medicine Therapeutic Area, with a specific focus on Immunology development programs. The individual functions with a strategic focus, a high degree of independence and provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.

You will independently manage projects, functioning as the single, accountable, global point of contact on those project teams and independently interact with Worldwide Regulatory Agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. This position requires a leader with a strategic mindset, and is  proactive, self-motivated, and who can independently manage complex programs that may involve multiple indications, formulations, or external partners. Prior experience in Immunology is strongly preferred.

Key Functions:

• Works both independently and as a team member with integrity, precision, accomplishment, respect, inclusion and a strategic mindset.
• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies.
• Utilizes regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling.
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle.
• Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
• Coordinates the preparation, submission and follow-up communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation.
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Interacts independently with regulatory agencies (FDA, EMA, etc.), including leading of regulatory meetings, teleconferences, and written communications.
• Leads cross-functional efforts to prepare for FDA advisory committees, as applicable.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepares IND/CTAs for global studies related to investigational drugs/biologics.
• Participates in regulatory due diligence activities for licensing candidate reviews.

Minimum Education & Experience Requirements:

• B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory or
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory

Required Experience:

• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective communicator—both written and verbal—with 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 strategies across global regions

• Global regulatory affairs experience in major markets (U.S., EU, Japan, China)

• 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.
  

Preferred Experience:

• Therapeutic area expertise in immunology

• Small and large molecule experience
• Prior people management experience.

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Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The primary location for this posting is:

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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