Specialist, Regulatory Affairs

Merck & Co.; Millsboro (DE); Hybrid; USD 87,000 - 137,000; Full time

Job summary

Merck & Co. seeks a regulatory affairs professional to support and track filings for animal health products, ensuring compliance with USDA regulations and licensure processes.

The role collaborates with GRA teams globally, maintains project schedules, and supports documentation controls in a regulated environment. You will interact with internal teams and regulatory agencies, manage multiple projects, and translate data into actionable reports while maintaining accuracy and attention to detail.

Qualifications

• Bachelor's degree and minimum 3 years regulatory experience.
• Experience in regulated industries (pharma/animal health/biotech/medical devices).
• Proficiency with Excel, Teams, SharePoint; familiarity with regulatory processes.

Responsibilities

• Maintain and manage trackers for timelines, submissions, milestones.
• Coordinate with stakeholders and regulatory agencies for submissions and information requests.
• Ensure compliance with applicable government regulations and document control practices.
• Support cross-functional teams and adapt to shifting priorities.

Skills

Regulatory compliance

Project management

Documentation control

Cross-functional collaboration

Attention to detail

Communication

Leadership

Education

Bachelor's degree

Tools

Excel

Teams

SharePoint

Project management software

Job description

For over 130 years, we have pioneered groundbreaking science.- Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology.- Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

SUMMARY OF POSITION

This position is responsible for supporting internal tasks and filings that ensure regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team.

This position is based in the US however closely working together with the GRA team located in the EU.

In this role, you participate in cross functional teams on maintenance of our products to provide support for filings made for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions.

MAJOR ACTIVITIES AND RESPONSIBILITIES

• This role provides project tracking, coordination, and administrative support for regulatory and compliance-related initiatives operating within a regulated environment. This role is responsible for maintaining project schedules, monitoring key milestones and deadlines, and ensuring accurate documentation of project status and deliverables
• Develops and maintains profound knowledge of all relevant regulatory requirements

JOB DESCRIPTION

• Maintain and manage spreadsheet-based trackers for project timelines, regulatory submissions, document outlines, and critical milestones.
• Track multiple concurrent projects and deadlines, ensuring timely completion of activities and effective communication of schedule changes.
• Translate and interpret information from project management software into actionable reports, trackers, and status updates for stakeholders.
• Utilize Microsoft Teams, SharePoint, and other collaboration platforms to organize project documentation, facilitate communication, and support cross-functional teams.
• Coordinate with internal stakeholders and external regulatory agencies to support submission activities, information requests, and regulatory commitments.
• Assist in maintaining compliance with applicable government regulations, policies, and procedures.
• Support document control and records management activities within a regulated environment.
• Adapt to shifting priorities, emerging business needs, and accelerated project timelines while maintaining accuracy and attention to detail.

REQUIRED EDUCATION & EXPERIENCE

• Bachelor's degree with a minimum of 3 years of regulatory experience.
• Experience working within a regulated industry such as pharmaceutical, animal health, biotechnology, medical device, food, or other government-regulated sectors.
• Familiarity with regulatory agencies and processes.
• Proficiency with Microsoft Office applications, particularly Excel, Teams, and SharePoint.
• Experience using project management software and reporting tools.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent people, communication, leadership skills and well-developed cultural awareness for involvement with cross departmental teams.
• -Excellent time and project management skills.
• Preferred: working knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines but is not required.-

Required Skills

Adaptability, Adaptability, Detail-Oriented, Document Controls, Document Management, Electronic Common Technical Document (eCTD), Employee Training Programs, Functional Management, Legal Compliance, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Progress Monitoring, Project Management Oversight, Project Management Tools, Project Planning, Project Tracking, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Strategy Development {+ 6 more}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer

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:

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.

EEOC Know Your Rights

EEOC Know Your Rights

EEOC GINA Supplement

EEOC GINA Supplement

Learn more about your rights, including under California, Colorado and other US State Acts

Learn more about your rights, including under California, Colorado and other US State Acts

Salary Range

The salary range for this role is
$87,300.00 - $137,400.00

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

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and 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

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

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/24/2026

*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

R415346