Job DescriptionJoin the Rahway, New Jersey Animal Health Team An experienced and dynamic Executive Director CMC (Chemistry, Manufacturing & Control) GRA (Global Regulatory Affairs) is sought to lead the global pharma CMC regulatory team and oversee the development and maintenance of pre- and post-approval regulatory strategies and submissions.
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.
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 HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only: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. 
