Associate Specialist – Regulatory Affairs

MSD

. Work closely with stakeholders on regulatory and safety submissions .

Posted 10/8/2026full-timePhiladelphia • Pennsylvania • United StatesJuniorMid-Level💰 $71,900 - $113,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong regulatory submission management skills, including the ability to create submission plans, manage regulatory documents, and maintain accountability for deliverables. Proficient in MS Office, particularly Excel and Word, with a focus on organization and attention to detail.

Highest-signal resume keywords

Regulatory Submission ManagementMS Office ProficiencyAdvanced Excel SkillsDocument Control SystemsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionSubmission PlanningDocument ManagementTimeline TrackingDeliverables Management

Soft Skills

Effective CommunicationProblem SolvingAttention to DetailLeadershipInitiative

Tools & Technologies

Computer SystemsMS Office

Industry Keywords

Regulatory SubmissionsFDA Cover LettersAccountabilityCustomer SatisfactionIndependent Thinking

About the role

Key responsibilities & impact

Work closely with stakeholders on regulatory and safety submissions
Assist with planning, execution, and management of high-quality, timely regulatory submissions
Maintain accountability for established planning and tracking practices and systems
Participate in pilots for new tools and processes
Collaborate with colleagues inside and outside the department
Participate in training courses to increase job-role skills and regulatory knowledge
Support creation of FDA cover letters and forms
Create submission plans
Assist in tracking deliverable timelines and submission components
Archive submission materials in systems
Provide regulatory submission and systems support
Manage regulatory documents
Track timelines, deliverables, and components
Respond promptly to updates

Requirements

What you’ll need

High School Diploma or equivalent
Ability to communicate effectively, verbally and in writing, with others across cultures and organizational levels
Ability to independently solve problems within the responsibilities and expectations of the role
Familiarity with computer systems
MS Office proficiency
Advanced Excel and Word skills preferred
Highly organized with keen attention to detail
Demonstrated leadership
Takes initiative
Ownership of deliverables
Accountability
Customer Satisfaction
Deliverables Management
Document Control Systems
Independent Thinking
Working Independently
Project Management preferred
Must be a US or Puerto Rico resident
No visa sponsorship available
10% travel required

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangement