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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Evaluate
We take the time to evaluate your needs beyond a job description
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We identify top talent from our research and competitive analysis
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What's New
Top Regulatory News Stories – Week Ending August 16, 2019
Harmony Biosciences announced today that the FDA approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). https://finance.yahoo.com/news/harmony-biosciences-announces-fda-approval-120000845.html The FDA has approved[…]
Top Regulatory News Stories – Week Ending August 9, 2019
Daiichi Sankyo announced that the US FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. https://www.prnewswire.com/news-releases/fda-approves-daiichi-sankyos-turalio-pexidartinib-for-the-treatment-of-select-patients-with-tgct-a-rare-and-debilitating-tumor-300895924.html Last week the FDA approved Bayer’s Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer.[…]
Regulatory Landscape Newsletter – August 2019
We saw regulatory hiring slow down slightly in July, which is fairly normal for the summer. There is still a high demand for Regulatory CMC, Regulatory Strategy, and Regulatory Advertising & Promotions professionals at all levels across the country. Hiring remains strong in the SF Bay Area and the Boston/Cambridge market. In July Dennis Partners[…]
Top Regulatory News Stories – Week Ending August 2, 2019
Celgene received FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease. https://www.pharmaceutical-business-review.com/news/celgene-otezla-behcets-disease/ Apic Bio, Inc. announced that the FDA has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS). http://www.firstwordpharma.com/node/1654288#axzz5uQCOiPcE Biohaven Pharmaceuticals reported that the FDA[…]
Top Regulatory News Stories – Week Ending July 19, 2019
Cellectar Biosciences announced the FDA has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). https://www.globenewswire.com/news-release/2019/07/09/1880139/0/en/Cellectar-Receives-FDA-Fast-Track-Designation-for-CLR-131-in-Diffuse-Large-B-Cell-Lymphoma.html Dicerna Pharmaceuticals announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1). https://www.businesswire.com/news/home/20190715005117/en/Dicerna-Receives-Breakthrough-Therapy-Designation-DCR-PHXC-Treatment/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J Neurocrine Biosciences said the FDA[…]
Top Regulatory News Stories – Week Ending July 12, 2019
Karyopharm Therapeutics announced that the U.S. FDA has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). https://www.globenewswire.com/news-release/2019/07/03/1878060/0/en/Karyopharm-Announces-FDA-Approval-of-XPOVIO-selinexor-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html Alexion’s Soliris received FDA approval for an additional indication last week. The drug is now approved to treat neuromyelitis optica spectrum[…]
Regulatory Landscape Newsletter – July 2019
For the month of June hiring in Regulatory continued to be strong, with a continued need for Labeling and Regulatory Advertising & Promotions professionals, along with clinical Regulatory Strategy people at the Director level. Most of the hiring demand is still coming from the Boston area and SF Bay Area, with a handful of positions[…]
Top Regulatory News Stories – Week Ending June 27, 2019
AMAG Pharmaceuticals announced that the U.S. FDA has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. https://www.amagpharma.com/news/amag-pharmaceuticals-announces-fda-approval-of-vyleesi-bremelanotide-injection-for-acquired-generalized-hypoactive-sexual-desire-disorder-hsdd-in-premenopausal-women/ Alexion’s drug Ultomiris has snagged a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage[…]
SRA Update July/August 2019
The Dichotomy of Inertia When it rains, it pours; most are familiar with this phrase. It’s what we use to describe the inertia of negative circumstances building and snowballing. Can you think of the equivalent phrase used to describe the opposite? The experience of positive inertia? “Just look at the bright side”… “turn lemons into[…]
Top Regulatory News Stories – Week Ending June 21, 2019
Blueprint Medicines announced it has submitted a NDA to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST. https://www.drugs.com/nda/avapritinib_190614.html?utm_source=ddc&utm The FDA announced that generic drug applicants will now have access to more information from the agency when deciding[…]