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Join our teamHyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, is always looking for exceptional candidates with relevant substantive experience or background. Candidates must have prior work experience in the government (e.g., FDA, DEA, HHS, or DOJ) or in-house at a life sciences company; portable business is bonus, but not required. Ideal candidates will possess strong verbal and writing skills and a detailed understanding of the regulatory construct governing our life sciences clients. Candidates must be members of the DC Bar or eligible to waive in.
Expertise in all things FDA
Experienced Regulatory Expert
Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced regulatory expert to our strong and busy team of non-attorney regulatory experts. Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics. Types of matters include:
- Developing regulatory strategy for manufacturing and related issues that arise in product development programs. Specifically, manufacturing/testing procedures and compliance with cGMPs.
- Reviewing test protocols and reports for small molecule or biologic drug programs.
- Meeting with FDA on behalf of clients or assisting clients seeking marketing authorization in preparing to meet with FDA and in other interactions with the Agency.
- Conducting internal investigations and audits of manufacturing facilities for compliance with 21 CFR 211/600.
- Preparing for and responding to government inspections and other compliance matters.
- Conducting due diligence on manufacturing facilities and products related to transactions and securities offerings
A background in chemistry, biochemistry, engineering, or biomedical engineering is preferred. Strong verbal and writing skills are required. Experience working at FDA in CDER or CBER for at least 2 years as a scientific reviewer or a consumer safety officer, with experience conducting inspections is strongly preferred.
The boutique, collaborative nature of this firm provides regulatory experts unique opportunities to work directly with clients and to contribute in substantive ways to sophisticated, high-end matters.
Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae and transcript to Deborah Livornese (dlivornese@hpm.com).
The staff of Hyman, Phelps & McNamara, P.C., is a diverse and dedicated team who work together to provide outstanding support to the firm’s clients. We offer a collegial work environment where employees’ efforts are recognized and valued.
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