Summary: The successful candidate for this position
will be someone with significant, specialized experience with global regulatory
requirements in the bio/pharma industry and a strong team orientation. This
Attorney will work with other Attorneys in the client’s Legal Department on
matters relating to regulatory requirements for investigational and approved
products, regulatory submissions, clinical trials, drug safety management,
labeling and label modification, as well as R&D and clinical compliance
regulations. The successful candidate will have direct client responsibility in
support of a broad range of company R&D related activity and may also serve
as a dedicated lawyer for one or more of client’s late stage development
programs. Position reports directly to the VP, Chief R&D
Specific responsibilities may include:
• Review and advise on key global regulatory
filings (sBLA/BLA) and briefing
• Work with cross functional pre-launch team to
develop product Client profile and Client labeling; anticipate and advise on
label and approval challenges.
• Provide regulatory environment (US and ROW)
updates on key activities at FDA, EMA and other global agencies that may affect
our product approvals and marketed products.
• Advise Drug Safety on recent developments in risk
• Proactively identify and manage risk profile of
products in development to be best prepared to prevent and address clinical
trial and post marketing products liability
• Work with Drug Safety to ensure compliance with
safety reporting, risk management and other post marketing safety
• 10+ years experience with global regulatory
requirements in the bio/pharma industry
• Experience with regulatory submissions,
requirements and drug safety management is
• Experience with government affairs, FDA and EMA
regulations are required.
• Must have excellent interpersonal, decision
making and communication skills.
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