Regulatory Analyst or Life Sciences Paralegal


The Life Sciences/Corporate practice of our national law firm client is seeking an experienced Regulatory Analyst or Life Sciences Paralegal. This mid-level 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. Successful candidates will have ability to self-start and work independently, excellent drafting, writing and analytical skills, accurate and strong attention to detail, high level of organization, strong verbal and interpersonal skills, and ability to manage multiple projects. Other duties include:
• Frequent travel and client interaction
• Exercising good judgement and discretion
• Managing large legal, regulatory and compliance projects
• Completing regulatory filings with FDA and states
• Due diligence review
• Drafting, proofreading and editing policies and procedures
• Researching and drafting articles and client training materials
• Performing compliance monitoring activities
• Other tasks as dictated by attorneys, senior paralegals and regulatory specialists

• 5+ years of professional experience, including 3+ 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
• Training/education
• Demonstrated knowledge of laws, regulations, guidance, and industry standards related to compliant commercialization of drugs and devices:
o FDCA and amendments
o HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers
o PhRMA and AdvaMed Codes
• The ideal candidate will be an active learner, highly organized, possess excellent proofing and communication (oral and written) skills; the ability to multitask in a fast-paced environment; a very strong attention to detail; and a professional demeanor.
• Strong interpersonal skills with the ability to work closely and build relationships with lawyers, clients and staff to achieve results. Requires a high level of collaboration with attorneys and staff and the ability to exercise independent judgment.
• Strong computer skills including proficiency in Word, Excel, PowerPoint and online research is a must.
• Must be willing to travel.
• Bachelor’s degree is required; MS in Regulatory Affairs or Regulatory Science or RAC credential preferred.

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