Associate Principal Scientist (Associate Director) Regulatory Affairs (Vaccines & ID)

Job Description

Brief Description of Position

The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence.

Primary activities include, but are not limited to:

• Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.

• Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications.

• Communicates with agencies and attending agency meetings to assist the Global Liaison.

• Participates as an active member on the Global Regulatory Team. They will attend cross-funnal meetings as required, in collaboration with, and to assist the global liaison.

• Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring of regulatory strategy documents.

• Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment).

• Supports maintenance (e.g., quality compliance and life cycle management) of VID programs.

• Supports of Global Liaison in label development.

• Assists with process improvement initiatives.

• Performs regulatory administrative activities as needed.

Division/Area

Research and Development Division – Global Regulatory Affairs and Clinical Safety

Job Level/ Grade 

400

Reports to

Global Regulatory Liaison, Executive Director or Associate Vice President, Section Head

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 or bachelor’s with experience to suggest equivalent ability to function in this position.

Required Experience and Skills:

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master’s degree with at least 3 years of relevant experience in pharmaceutical industry, or

• Bachelor’s degree with at least 6 years of relevant experience in the pharmaceutical industry

• 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.

Preferred Experience and Skills:

• Prior regulatory experience.

• Experience in drug development, particularly anti-infectives and/or vaccine products is highly preferred.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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