Job Description

The Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in planning, execution, and management of activities that deliver high quality and timely regulatory submissions. Additionally, the incumbent may be involved in supporting internal and/or external process improvement designed to improve the efficiency and effectiveness of the RPP processes and deliverables.

The responsibilities of the incumbent may include the following:

• In collaboration with the submission planning team, actively participate in planning forum meetings to assist with submission activities and identifying, assessing, and communicating any risks/ issues that could impact the successful completion of submissions.

• Help identify business process improvement opportunities, documentation updates, and/or training to prevent practices which could lead to quality deviations or non-compliance events.

• Liaise with all areas of the RPP organization to ensure timely and quality submissions, as the business requires.

• Create and maintain submission plans in the planning tool to ensure correct components and timelines are captured.

Required Skills and Experience:

• Bachelor’s degree in a Life Science, Pharmacy or Engineering related discipline.

• Minimum of 2 years' work experience within a healthcare/consumer care industry, project management, regulatory affairs, and/or pharmacovigilance/risk management function.

• Ability to communicate in English effectively, both verbally and written, in a cross-functional setting and across levels within a matrix organizational structure.

Desired Skills:

• Ability to understand tactical details but keep overall “big picture” view of projects and strategies.

• Self-starter, fast learner with analytic and problem-solving capabilities and the ability to innovate and perform in a fast-paced team environment.

• Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills preferred).

• Highly organized individual with keen attention to detail.

• Demonstrated leadership, initiative, and ownership of deliverables.

• Effective at energizing others, establishing clear goals, delegating responsibility, mentoring, and coaching.

Required Skills:

Accountability, Accountability, Business Processes, Business Process Improvements, Clinical Research, Clinical Trial Planning, Coaching, Component Verification, Detail-Oriented, Documentations, Ethical Standards, Interpersonal Relationships, Labeling Compliance, Medical Writing, Organizational Performance Management, Organizational Structures, Pharmaceutical Quality Assurance, Pharmacovigilance, Process Improvements, Product Lifecycle Management (PLM), Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Audits, Regulatory Compliance {+ 3 more}

Required Skills:

Accountability, Accountability, Adaptability, Business Processes, Business Process Improvements, Clinical Research, Clinical Trials, Detail-Oriented, Documentations, Electronic Common Technical Document (eCTD), Employee Training Programs, Medical Writing, Mentorship, Pharmaceutical Quality Assurance, Pharmaceutical Quality Control (QC), Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Lifecycle, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

03/31/2026

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