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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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[…]
This week the FDA approved two new products and announced a new pilot program for orphan drug designations. Celgene received a Refusal to File letter and Allergan’s PDUFA date was delayed. And the EMA provided more details regarding their new premises in Amsterdam. Here are the top regulatory news stories for this week: KemPharm announced[…]
When you communicate with someone, what are you thinking about? Are you thinking about what you want to say or the impact you want to have? You may feel confident about your message, but will the delivery be received in the manner intended? Have you considered who your audience is – employees, managers, friends, or[…]
Hi folks. This was a relatively quiet week without the approval of any new molecular entities. Here is my recap of the top regulatory news stories this week: The FDA agreed to expand the label for AstraZeneca’s immunotherapy Imfinzi (durvalumab) to reduce the risk of non-small-cell lung cancer progression in patients with stage III[…]
This week was saw the approval of two new molecular entities by the FDA while Apricus received a Complete Response Letter. Here is my recap of the top regulatory news stories for this week… Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor and ivacaftor) has been approved by the FDA to treat the underlying cause of cystic[…]
Most of us associate the term “brand” with companies or sports figures which market their products or personas. The billions of dollars that are invested each year into building and maintaining these brands demonstrates the importance of branding. As an individual, you have a brand as well. There are 3 components to your personal brand[…]
The FDA on Wednesday approved Biktarvy, Gilead Sciences’s once-daily, triple-combination tablet for treatment of HIV infection https://www.reuters.com/article/us-gilead-sciences-fda/u-s-fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ? Spectrum Pharmaceuticals plans to file a BLA for approval of its chemotherapy side effect drug Rolontis later this year based upon positive results from a Phase 3 study https://www.biopharmadive.com/news/spectrum-advances-neutropenia-drug-toward-fda-filing/516408/ Zogenix has won the FDA’s breakthrough therapy designation for[…]
This week saw a rejection by the FDA for Aradigm, a clinical hold for Bellicum, and a black box warning for Intercept. In addition, the FDA granted a Breakthrough Therapy designation along with a Fast Track designation. Here are the top regulatory stories for the week: The FDA has rejected Aradigm’s inhaled antibiotic Linhaliq[…]