Job Description

Department- Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease

Brief Description of Position-

The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.

Primary activities include, but are not limited to:

• Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.

• Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.

• Provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products.

• Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our Company and FDA; prepares our Company teams for meetings with FDA at all phases of drug development.

• Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.

• Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.

• Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators Brochures before release from our company to external agencies and investigators.

• Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.

• Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.

• Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products.

Location- USA-Pennsylvania-North Wales-Upper Gwynedd

Additional Locations:

USA-New Jersey-Rahway

USA-Pennsylvania-Philadelphia-WeWork

Extent of Travel - 10%

Qualifications, Skills & Experience

Education Minimum Requirements:

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.

Required Experience and Skills:

• M.D. with minimum of 3 years relevant drug development or clinical experience required, or

• Ph.D. with minimum of 5 years relevant drug development experience required, or

• M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs.

• Excellent communication skills (both oral and written).

• Good organizational skills with a proven ability to simultaneously balance diverse activities or multiple projects.

• Flexibility required.

• Strong scientific and analytical skills with attention to detail.

• Ability to achieve optimal results with limited day-to-day direction from the manager.

Preferred Experience and Skills:

• Substantial experience in regulatory affairs.

• Therapeutic area experience in vaccines or infectious diseases.  Experience with antibacterial, antifungal or antiviral agents.

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.