At Dennis Partners, we know regulatory recruiting. We are committed to creating and maintaining partnerships with our clients while upholding the highest standards of professionalism and ethics. Our team interacts within the marketplace on a daily basis, giving us the ability to locate, screen, and recommend exceptional individuals to your firm. We know how to identify the top performers. Our strength is partnering with you and your business to develop a solution and meet demands for growth while improving efficiency. Let our advanced expertise find the top professionals in the industry to provide a competitive edge to your company.
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Dennis Partner’s focus on only regulatory affairs searches gives them a very good sense of the market, the available talent, and who matches the role. They worked with us diligently to find the right candidate and we ended up making an exceptional hire.
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Rigel Pharmaceuticals announced that the FDA approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. https://www.prnewswire.com/news-releases/rigel-announces-fda-approval-of-tavalisse-fostamatinib-disodium-hexahydrate-for-chronic-immune-thrombocytopenia-itp-in-adult-patients-300631702.html Ultragenyx and Kyowa Kirin announced FDA approval of Crysvita® (burosumab-twza) for the treatment of children and adults with X–Linked Hypophosphatemia http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-kyowa-kirin-announce-fda-approval-crysvitar[…]
In the process of planning your next Strategic Career Move, the value of Interview Preparation can never be taken lightly. Too often I find myself explaining to candidates the importance of being fully prepared for an interview. This preparation is paramount to your success, no matter what the position or level may be. On the[…]
This was a relatively busy week with new draft guidances, new orphan drug designations, two supplemental approvals, and the lifting of a clinical hold. Here are the top regulatory stories for this week: The Food and Drug Administration has approved the first artificial intelligence software that can decide, without a clinician’s involvement, whether a patient[…]
This week saw the submission of two new NDAs, two complete response letters, and one refusal to file. Here are the top regulatory news stories for this week: Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461, a once-daily, oral investigational medicine with a novel[…]
Every day we have challenges, some are bigger, some are smaller, and some get to the point where they almost break us, where we feel we can’t take anymore. And yet, that’s where we can experience a fork in the road – one is to crumble and do nothing and the other is to plow[…]
Hey folks, I’m posting this a day early since I will be taking off for a long weekend. Here are the top regulatory news stories for this week: The EMA’s Committee for Medicinal Products for Human Use (CHMP) rejected two drugs where were approved by US FDA in 2017 (betrixaban and abaloparatide): https://www.raps.org/news-and-articles/news-articles/2018/3/ema%E2%80%99s-chmp-rejects-two-drugs-approved-by-us-fda-in GSK’s Shingrix[…]
This week saw the approval for Sun Pharma’s first biologic program along with a supplemental approval for Seattle Genetics. Here is my recap of the top regulatory news stories for this week: The FDA on Monday officially launched its pilot project to publicly release portions of clinical trial-related summaries from pivotal trials, with initial data[…]
This week the FDA granted Breakthrough Therapy status to three development programs and halted two different clinical trials. Here are the top regulatory news stories to follow this week: Ocular Therapeutix, which had its lead drug rejected by the FDA last summer said that it remains on track to resubmit its application to the FDA[…]
The time to start building a list of professional references is far before you start interviewing for your next strategic career move. One of the biggest mistakes candidates make is failing to understand how incredibly important references are to the hiring process. When preparing candidates for the interview, I inform them of the significance of[…]
This week we saw the approval of a new molecular entity by the FDA along with the first marketing authorization approval for a genetic health risk assessment. Here is my recap of the top regulatory news stories for this week: The FDA approved TaiMed Biologics’ Trogarzo (ibalizumab-ulyk) for the treatment of adults with chronic HIV[…]