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Job Description

SUMMARY OF POSITION

This position is responsible for ensuring 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/drive filings for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions.

MAJOR ACTIVITIES AND RESPONSIBILITIES

All major activities and responsibilities below would approximate 100% of time spent in the role, where applicable. Individual activities and responsibilities listed below may fluctuate beyond > 25% of time spent depending on company needs.

+ When proficient in the job role, provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.

+ Additionally, may assist as an Alternate Liaison with the USDA for pre or post-regulatory responsibilities to include submissions and communications with the USDA, internal MAH departments or international permittees, where applicable.

+ May serve as subject matter expert in regulatory matter(s), such as but not limited to labeling, facility documents, relative Potency assays, antigen overages, licensure processes, permits, ingredients of animal origin and ensure that these meet the requirements of the USDA and export markets.

+ Develops and maintains profound knowledge of all relevant regulatory requirements.

+ Travel (≥ 10%) might be needed.

JOB DESCRIPTION

+ Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA (Examples of submission include but not limited to label packaging, reports/protocols/raw data, individual study summaries (ISS), outlines of production and special outlines). Alternatively, may review and prepare registration documents for export markets.

+ May serve as point of contact for GRA internation dossier/registration questions for new submissions, renewals and variations for US biologicals filed with local CORA, where applicable. Additionally, may lead in creation of GRA standard international dossiers for US Biologicals.

+ May review market advertising and promotions (A&P) for US Biologicals in compliance with USDA regulations and product license filings, including but not limited to technical bulletins, journal articles, presentations, routine A&P.

+ May prepare and maintain regulatory documents and communications regarding US biological restricted products with US state veterinarians for approval and compliance. Support state registrations for US Biologicals, when applicable.

Required experience and skills:

+ Bachelor’s degree with a minimum of 5 years of regulatory experience, or Master’s degree with a minimum of 3 years of regulatory experience in the vaccine industry.

+ Minimum of (regulatory) experience within the (veterinary) pharmaceutical industry (preferable biologicals).

+ Preferred working knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines. Excellent time and project management skills. Excellent people, communication, leadership skills and well-developed cultural awareness for involvement with cross departmental teams.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$104,200.00 - $163,900.00

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.

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 .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Job Posting End Date:

08/14/2025

*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:** R359445