Senior Specialist, Regulatory Affairs | US Biologicals at Merck Sharp & Dohme Corp. /Netherlands

Millsboro, Delaware, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

167200.0

Posted On

01 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Accountability, Adaptability, Assay, Audits Compliance, Biochemical Assays, Biopharmaceutical Industry, Biosecurity, Detail-Oriented, Documentations, Drug Regulatory Affairs, Licensing Law, Manufacturing Compliance, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Strategy Development

Industry

Pharmaceutical Manufacturing

Description

Job Description Senior Specialist, Regulatory Affairs | US Biologicals At our company, we are dedicated to advancing the prevention and treatment of diseases in both people and animals through innovative health solutions. As a Senior Specialist in Regulatory Affairs for US Biologicals, you will play a crucial role in ensuring our animal health products meet regulatory standards. Join us in our mission to use leading-edge science to save and improve lives around the world. Responsibilities Ensure regulatory filings of animal health products comply with applicable USDA regulations. Provide USDA regulatory guidance and strategy with interdepartmental teams for pre and post-license activities of US Biologicals. Assist as an Alternate Liaison with the USDA for pre or post-regulatory responsibilities, including submissions and communications. Serve as a subject matter expert in regulatory matters such as labeling, facility documents, relative potency assays, antigen overages, licensure processes, permits, and ingredients of animal origin. Represent the company's Animal Health division on working groups as defined by the Animal Health Institute. Review, prepare, and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA. Serve as the point of contact for GRA international dossier/registration questions for new submissions, renewals, and variations for US Biologicals filed with local CORA. Lead the creation of GRA standard international dossiers for US Biologicals. Review market advertising and promotions (A&P) for US biologicals to ensure compliance with USDA regulations and product license filings. 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. Qualifications Required Bachelor's degree in scientific or related areas of study with five years of regulatory experience, or a Master's degree with three years of regulatory experience. Knowledge of USDA requirements and regulations relating to the manufacturing and research and development of biological vaccines. Effective time and project management skills. Strong people, communication, and leadership skills for involvement with cross-departmental teams. Preferred Prior experience in the vaccine, pharmaceuticals, or biological industry. Required Skills: Accountability, Accountability, Adaptability, Assay, Audits Compliance, Biochemical Assays, Biopharmaceutical Industry, Biosecurity, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Licensing Law, Manufacturing Compliance, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulations, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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, 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. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model 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 $106,200.00 - $167,200.00 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. 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 Job Posting End Date: 03/2/2026 *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:R386367

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Responsibilities

The specialist will ensure regulatory filings for animal health products adhere to USDA regulations and provide regulatory guidance and strategy for pre and post-license activities of US Biologicals. This role involves serving as a subject matter expert on regulatory matters and representing the Animal Health division on working groups.