Job

Regulatory Analyst/Paralegal - Life Sciences

Job ID: 5190
Location: New York, NY
Category: Paralegal

Our client, the New York office of a prominent national law firm, seeks an experienced Life Sciences Regulatory Analyst or paralegal to join its Life Sciences group.

This midlevel position will support the legal team of partners, associates, paralegals and regulatory specialists. The ideal candidate must have at least 5 years of professional experience, 3 of which must be in the pharmaceutical/biologic/medical device legal, regulatory or compliance field.

Candidates must have at least three years of experience working in pharmaceutical/biologic/medical device legal, regulatory or compliance, working on tasks such as:

·         Regulatory operations, including FDA and state regulatory filings

·         Regulatory intelligence

·         Regulatory strategy

·         Risk management

·         Domestic or international compliance

·         Creation and implementation of policies and procedures

·         Monitoring and auditing

·         Legal-Medical-Regulatory promotional materials review

Candidates must exhibit knowledge of laws, regulations, guidance, and industry standards related to compliant commercialization of drugs and devices including FDCA and amendments, HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers, and PhRMA and AdvaMed Codes.

Some travel may be necessary.

Bachelor’s degree is required; MS in Regulatory Affairs or Regulatory Science or RAC credential preferred.

Please send your resume to ebienenfeld@yorkson.com.