Associate Specialist - Regulatory Affairs (Hybrid)

Merck; Philadelphia (Philadelphia County); Hybrid; USD 72,000 - 113,000; Full time

Job summary

Merck is seeking an Associate Specialist in Regulatory Planning & Publishing in Philadelphia, PA on a hybrid schedule (3 days in-office). The role supports planning, execution, and management of timely regulatory submissions and documents.

Responsibilities include creating submission plans, FDA cover letters, and tracking deliverables while collaborating across teams and participating in training to enhance regulatory knowledge.

Qualifications

• High School Diploma or equivalent required.
• Ability to communicate effectively across cultures and levels.
• Familiar with MS Office; Advanced Excel and Word skills preferred.
• Highly organized with keen attention to detail.

Responsibilities

• Maintain accountability for established planning and tracking practices.
• Participate in pilots for new tools and processes.
• Collaborate with colleagues inside and outside the department.
• Assist in creation of submission plans and FDA cover letters.
• Manage regulatory documents and track timelines/deliverables.

Skills

Accountability

Communication

Computer Literacy

Customer Satisfaction

Deliverables Management

Document Control Systems

Independent Thinking

Microsoft Word

Taking Ownership

Working Independently

Project Management

Education

High School Diploma or equivalent

Tools

MS Office

Advanced Excel and Word

Job description

Job Description

The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.

This position is based at the Philadelphia, PA, WeWork Office, on a hybrid basis- 3 days in office; The incumbents will be required to commute to the Philadelphia, PA, WeWork Office, for these 3 days.

The Responsibilities Of The Incumbent May Include The Following

• Maintain accountability for use of established planning and tracking practices and systems.
• Participate in pilots for new tools and processes.
• Collaborate with colleagues inside and outside of the department, as appropriate.
• Participate in training courses to increase job role skills and regulatory knowledge.

Program

• Support in the creation of FDA cover letters and forms, creation of submission plans, assist in tracking deliverable timelines of components, and archiving in systems.

Shared Services

• Provide regulatory submission/systems support.
• Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates.

Education Minimum Requirement

• High School Diploma or equivalent.

Required Qualifications, Skills & Experience

• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels.
• Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role.
• Familiar with computer systems (MS Office necessary; Advanced Excel and Word skills preferred).
• Highly organized individual with keen attention to detail.

Desired Experience & Skills

• Demonstrated leadership.
• Takes initiative.
• Ownership of deliverables.

Required Skills

• Accountability
• Communication
• Computer Literacy
• Customer Satisfaction
• Deliverables Management
• Document Control Systems
• Independent Thinking
• Microsoft Word
• Taking Ownership
• Working Independently

Preferred Skills

• Project Management

Equal Employment Opportunity Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

• EEOC Know Your Rights
• EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Salary

The salary range for this role is $71,900.00 - $113,200.00

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.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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

Employee Status

Regular

Relocation

No relocation

Visa Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/15/2026

• 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.

Requisition ID

R419988