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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in providing legal support for manufacturing compliance, particularly in cGMP, while effectively managing legal risks and regulatory interactions. Strong analytical and communication skills are essential for advising business clients and navigating complex regulatory environments.
Highest-signal resume keywords
Regulatory ExperienceCGMP KnowledgeLegal Advice on Manufacturing AgreementsExperience with FDA and EMATeamwork and Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceLegal CounselingRegulatory Submissions ReviewManufacturing ComplianceLegal Risk Management
Soft Skills
Analytical SkillsCommunication SkillsBusiness AcumenTeamwork
Certifications & Qualifications
Bachelor's DegreeLaw DegreeAdmission to the Bar of New Jersey
Industry Keywords
CGMPPharmaceuticalRegulatory AuthoritiesFDAEMA
About the role
Key responsibilities & impact- Provide legal support and counseling to business clients on manufacturing compliance issues, including cGMP, around the world
- Provide timely, practical and compliant solutions while managing legal risks
- Report to the Associate Vice President, Legal - Manufacturing Regulatory, Labor & Employment, and Safety & Environmental
- Provide day-to-day legal advice to quality and supply chain organizations
- Review regulatory submissions and provide strategic advice on interactions with regulators
- Provide legal support for regulatory inspections
- Maintain understanding of current Good Manufacturing Practices (cGMP)
- Provide advice on manufacturing-related agreements
Requirements
What you’ll need- A bachelor's degree from an accredited institution
- Graduate of an accredited US law school
- 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
- High degree of business acumen
- Experience managing a significant workload and juggling competing tasks in a fast-paced and challenging environment
- Willingness to work from an office in Rahway, New Jersey or North Wales, Pennsylvania at least three days a week
- cGMP experience preferred
- Pharmaceutical experience preferred
- Experience dealing with regulatory authorities, such as FDA and EMA, preferred
- No visa sponsorship
Benefits
Comp & perks- Hybrid work arrangement: 3 days per week in office
- No relocation
- 10% travel requirements
- Regular employee status