Major, Lindsey & Africa's Interim Legal Talent group has an immediate need for an Interim Regulatory Compliance Counsel (TTP).
Overview: Our client is seeking an experienced Interim Regulatory Compliance Counsel with a wide range of compliance experience.
Company: Global pharmaceutical leader
Experience: Candidates should have 7+ years of experience with a heavy emphasis on regulatory compliance at a global company
Location: Hybrid in Parsippany, NJ, Westchester, NY, or Washington, DC
Responsibilities Include:
We seek an experienced Interim Regulatory Compliance Counsel with a wide range of compliance experience to assist with GMP efforts, assure adherence to GxP guidelines and standards in laboratories and R&D facilities, manufacturing and distributing processes, lead internal investigations, spearhead remediation processes, and communicate with the appropriate regulators. Ideally, candidates will have 7+ years of experience with a heavy emphasis on regulatory compliance at a global company. Candidates will be tasked with:
Implementing and maintaining the audit program to support all GxP efforts
Coordinating with internal and external stakeholders and communicating with regulatory authorities
Coordinating and managing risk assessment activities
Leading and/or assisting with cross-functional inspection readiness and preparedness activities
Conducting regulatory inspections
Travel is required 25% of the time; it does count towards the "in-office" requirement for this position
Qualifications Include:
A Juris Doctor (JD) degree from a top-tier law school is required. Must be licensed and in good standing in at least one US jurisdiction.
7+ years of regulatory compliance experience; global company experience is a must.
Strong relationship-building skills, able to influence internal and external stakeholders. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility.
Must be available to travel 25% of the time.
Information regarding benefits can be found on MLA's Website on the Consultant Resources Page: https://www.mlaglobal.com/en/consultant-resources
All interested and qualified candidates should apply directly with Major, Lindsey & Africa for review and consideration.
Major, Lindsey & Africa does not discriminate against applications on the basis of age, sex, race or any other protected characteristics pursuant to applicable state or federal laws.