Specialist - Regulatory Planning & Publishing

MSD; Rahway (NJ); Hybrid; GBP 50,000 - 75,000; Full time

Job summary

Merck & Co., Inc. in the United Kingdom seeks a Specialist of Regulatory Planning & Publishing to assist in planning, execution, and management of high-quality regulatory submissions.

The role collaborates with multiple stakeholders to identify risks and drives process improvements to enhance efficiency. Responsibilities include participating in planning forums, maintaining submission plans, and ensuring timely, compliant submissions.

Qualifications

• Bachelor’s Degree plus 2 years of relevant experience.
• Strong English communication in a cross-functional setting.
• Ability to manage tactical details and keep big-picture project view.
• Self-starter with analytical and problem-solving abilities.

Responsibilities

• Participate in planning forum meetings to assist submission activities and communicate risks that could impact timely submissions.
• Identify process improvements, update documentation, and support training to prevent deviations or non-compliance.
• Liaise with all areas of the RPP organization to ensure timely, quality submissions.
• Create and maintain submission plans in the planning tool to capture components and timelines.

Skills

Adaptability

Business Agility

Regulatory Affairs

Pharmacovigilance

Process Improvements

Regulatory Compliance

Regulatory Management

Regulatory Reporting

Matrix Management

Microsoft Word

Pharmaceutical Regulatory Affairs

Learning Agility

Regulatory Documents

Detail-Oriented

eCTD

Education

Bachelor’s Degree + 2 years experience

Tools

MS Office

Advanced Excel

MS Word

Job description

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 or external process improvement designed to improve the efficiency and effectiveness of the RPP processes and deliverables.

Responsibilities

• 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.
• 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.

Education Minimum Requirement

• Bachelor’s Degree plus 2 years of relevant experience.

Required Experience and Skills

• Minimum of 2 years of 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
• 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

• Adaptability
• Adaptability
• Business Agility
• Competency Management
• Computer Literacy
• Detail-Oriented
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• Ideation
• Learning Agility
• Legal Compliance
• Matrix Management
• Microsoft Word
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Process Improvements
• Regulatory Affairs Compliance
• Regulatory Affairs Management
• Regulatory Communications
• Regulatory Compliance
• Regulatory Documents
• Regulatory Experience
• Regulatory Management
• Regulatory Processes
• Regulatory Reporting {+ 5 more}

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

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:
09/26/2026*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.