Primary Responsibilities:

Evaluate workload, ensure timely staffing onboarding, and training. Monitor performance, provide feedback, and conduct routine staff meetings. Collaborate with manufacturing, quality, technical support, R D, and marketing to meet submission milestones. Review regulatory submissions and provide input for timely pharmaceutical product approval and launch. Support the team members to work effectively with other functions to develop robust regulatory strategies and high-quality regulatory submissions. Develop and maintain standard processes and systems for regulatory compliance. This may involve leading complex projects related to these processes or systems. Build and apply knowledge of current regulations for pre- and post-approval submissions. Act as the primary liaison with regulatory authorities, including FDA CVM and US Agent. Communicate regulatory information and achievements within the company and to management. Actively lead or participate on various internal project teams, as needed. Perform other tasks as requested by management.

Education:

Bachelor's degree in science, engineering, or relevant field (advanced degree preferred).

Required Experience and Skills:

Minimum 15 years of global regulatory and/or product development experience, including supervisory roles in the area of chemistry, manufacturing and controls (CMC). Strong written and oral communication skills. Excellent people, communication, and leadership skills. Highly organized with effective time management and attention to detail.

Preferred Experience and Skills:

Experience critically reviewing detailed scientific information to ensure information is presented clearly and conclusions are supported by data. Strong understanding of related fields (biopharmaceutical manufacturing, analytical, quality assurance, and R D). Strong written and verbal communication skills in multicultural settings and ability to communicate in a succinct, logical manner. Experience with regulatory requirements for mABs and sterile products. Animal Health Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services. We invest in dynamic and comprehensive R D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Required Skills:

Biopharmaceuticals, Confidentiality, Global Health, Manufacturing, Mentoring Staff, People Leadership, Pharmaceutical Biology, Pharmaceutical Regulatory Affairs, Project Management, Regulatory Affairs Compliance, Regulatory Compliance Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Training, Strategic Thinking 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 The salary range for this role is $231,900.00 - $365,000.00 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:

Domestic 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:

08/5/2026 •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:

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