Specialist, Regulatory Affairs

Job DescriptionFor 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.Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.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 deliverablesDevelops and maintains profound knowledge of all relevant regulatory requirementsJOB 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}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 RightsEEOC 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 ActsThe salary range for this role is$87,300.00 - $137,400.00This 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 .You can apply for this role through (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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob 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. SummaryLocation: USA - Delaware - De MillsboroType: Full time