Job DescriptionThe position provides legal support and counseling to business clients on a wide range of manufacturing compliance issues (including cGMP) around the world. The position requires the ability to provide timely, practical and compliant solutions while managing legal risks. The position reports to the Associate Vice President, Legal - Manufacturing Regulatory, Labor & Employment, and Safety & Environmental. This is a hybrid role 3 days/ week in office. Ideally the candidate will work in our Rahway NJ office but also open to our West Point, PA or Upper Gwynedd, PA locations.
Responsibilities include:- Providing day-to-day legal advice to the quality and supply chain organizations;
- Reviewing regulatory submissions and providing strategic advice on interactions with regulators;
- Providing legal support for regulatory inspections;
- Maintaining understanding of current Good Manufacturing Practices (cGMP);
- Providing advice on manufacturing-related agreements.
Required Qualifications & Skills:
- A bachelor's degree from an accredited institution.
- Graduate of an accredited US law school, with admission to the Bar of New Jersey or another state.
- Five (5) or more years of regulatory experience in a law firm or corporate setting
- Excellent teamwork, communication (written and oral) and analytical skills, and a high degree of business acumen;
- Experience in managing a significant workload, with the ability to juggle competing tasks in a fast paced and challenging environment;
- Willingness to work out of an office in Rahway, New Jersey or North Wales, Pennsylvania no fewer than three days a week.
Preferred Expereince:
- cGMP experience;
- Pharmaceutical experience;
- Experience dealing with regulatory authorities, such as FDA, EMA
OGC2026
Required Skills: Preferred Skills:Business Administration, Business Case Development, Business Communications, Business Law, Business Management, Business Systems, cGMP Regulations, Client Management, Client Representation, Collaborative Development, Commercial Acumen, Corporate Management, Counseling Services, FDA Regulations, Legal Risk, Organizational Behavior, Performance Management Tool, Plan of Action and Milestones (POA&M), Quality Control Systems, Quality Management, Stakeholder Engagement, Strategic Planning, Strategic Supply Chain Management, Written Communication
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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:1st - Day
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:09/23/2026
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