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Compensation : Base salary up to $220k, Plus Bonus, Plus LTI. Scientific Search has recently partnered with an innovative biopharmaceutical company who has tasked us in finding them a Director, Regulatory Affairs. Support European development-stage regulatory activities, including contribution to CTA and MAA strategies and filings (execution will be led by regional team). Bachelor’s degree in life sciences required; advanced degree (MS, PharmD, PhD, or equivalent) strongly preferred.. Prior involvement in European regulatory strategy and filings (e.g., CTA, MAA) preferred
The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics (“company”) from development through marketing approval and commercialization. The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs. Knowledge of EU MDR regulations is required.. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
Their reach is global and they are the industry leader in their specialty, with a second location in Asia. The investment into R&D is significant with several products in the pipeline at various stages and their financial standings are strong.. The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed.. Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization, or packaging and notify regulatory agencies and NB of substantial changes.. 5-10 years experience in regulatory affairs within the medical device industry. Authoring experience in FDA product submissions (IDE, PMA, 510k)
Inspira Talent is currently partnered with a nimble biotech in SF Bay developing novel biologics for autoimmune disease.. The Head of Regulatory Affairs leads regulatory strategy and operations across this biotech's development programs.. 10+ years in pharma/biotech, with 3+ years immunology/autoimmune experience. Deep understanding of preclinical, clinical, and regulatory processes.. Biotechnology Research and Pharmaceutical Manufacturing
Submissions: Prepare, review, and submit regulatory documents, including 510(k)s, PMAs, Technical Files, Design Dossiers, and other regulatory submissions for FDA, EU MDR/IVDR, and other international markets.. Cross-Functional Collaboration: Partner with R&D, Quality, Marketing, and other departments to support product development, labeling, and market access strategies.. 5+ years of experience in regulatory affairs within the medical device or IVD industry.. Proven track record of successful regulatory submissions (e.g., 510(k), PMA, CE Mark).. Strong knowledge of global regulations, including FDA, EU MDR/IVDR, Health Canada, and other international requirements.
Their reach is global and they are the industry leader in their specialty, with a second location in Asia. The investment into R&D is significant with several products in the pipeline at various stages and their financial standings are strong. The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization, or packaging and notify regulatory agencies and NB of substantial changes. Qualifications 5-10 years experience in regulatory affairs within the medical device industry.. Authoring experience in FDA product submissions (IDE, PMA, 510k)
Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond. This role is responsible for the development and execution of regulatory strategy across all functions, including preclinical and clinical development, CMC, and eventual commercialization. Partner with internal stakeholders (R&D, CMC, Clinical Operations, Corporate Strategy, Legal, etc. Minimum of 15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including at least 8 years in leadership roles. Deep understanding of regulatory guidance, quality standards (GxPs), and global health authority expectations across therapeutic modalities, with emphasis on RNA, lipid nanoparticle, gene, or cell therapy platforms.
Senior Manager, Talent Acquisition at Bicara Therapeutics. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β).. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment.. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.. Senior Project Manager - Luxury Residential Construction
Clinical-Stage Biotech | Bay Area | Hybrid (2-days on-site). Proclinical is partnering with a rapidly growing clinical-stage company advancing a high-potential pipeline in the immunology space.. With multiple assets in mid-stage development, they're looking to bring on a Senior Regulatory Affairs Leader to drive global strategy across a dynamic portfolio.. 10+ years of Regulatory Affairs experience in development-stage biotech. Director Life Sciences Regulatory Affairs and Labeling Senior Manager/Associate Director Clinical Quality Assurance Auditor We’re unlocking community knowledge in a new way.
The Senior Regulatory Affairs Specialist (Advertising & Promotional Review) leads the end-to-end review process for promotional and non-promotional content across Stallergenes Greer portfolio of products.. Ensures all materials comply with Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and Office of Prescription Drug Promotion (OPDP), and other regulatory requirements while fostering a culture of collaboration and compliance.. Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off processes.. 3 - 5 years’ experience in biopharmaceutical and/or medical device Regulatory Affairs, with specifically 1+ year in advertising and promotional review.. Proven experience working with Veeva PromoMats and supporting submissions to CBER/OPDP.
In this role, you contribute to the development and implementation of a consolidated regulatory strategy (including Regulatory Operations) to secure and maintain regulatory approvals across the product lifecycle. The ideal candidate brings proven global experience navigating complex regulatory environments, particularly in oncology and rare disease, and thrives in a dynamic, mission-driven biotech setting. Bachelor's degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred. Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
This clinical-stage, neuromuscular biotech has a diversified pipeline of gene therapy programs across neuromuscular and cardiac diseases.. We are looking for a Director of Regulatory Affairs with gene therapy experience to oversee all aspects of regulatory submissions (operations and strategy).. This person will be working closely with the company's next-generation gene therapy programs.. BS, Master's, PharmD, or PhD preferred.. Previous gene therapy experience
A pivotal aspect of this position involves leading the strategic planning of the U.S. Biologics License Application (BLA) preparation and defense, as well as coordinating activities related to FDA Advisory Committee (AdComm) meeting preparation.. Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred.. Experience with European MAA is preferred.. Proficiency with Veeva RIM, including training others and managing regulatory commitments.. Knowledge of ICH guidelines and FDA regulatory requirements.
B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.. Certification in Regulatory Affairs (RAC) and other relevant certifications an asset. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.. Accessibility Policy AmerisourceBergen is committed to fair and accessible employment practices.. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
Responsible for regulatory, franchising, and public policy matters for City of Chicago, Cook County, and Northwest Indiana.. Develops and implements legislative strategies, monitors legislation and coordinates state association management.. Develops and implements strategy for government affairs and public policy issues for specific franchises as well as strategy for local regulatory initiatives.. Government Affairs, Leadership, Local Government, People Management, Strategy Implementation, Taking Initiative Compensation. Most sales positions are eligible for a Commission under the terms of an applicable plan, while most non-sales positions are eligible for a Bonus.
We're seeking an experiencedSenior Regulatory Affairs Specialistto support global regulatory submissions and compliance initiatives.. Provide regulatory guidance during FDA, Notified Body (e.g., BSI), and other regulatory inspections.. Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry.. Hands-on experience with 510(k), IDE, PMA, annual reports, MDRs, Vigilance Reports, and international registrations.. Confident public speaker and collaborative team player.
You shouldn’t have to be a tech expert or a math genius to take charge of your health.. 4+ years of Regulatory Affairs experience within medical device or other highly regulated industries. Must have working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions (CAPA). Knowledge of medical device processes in the following areas : reliability, sterilization, usability, software, cybersecurity, biocompatibility, performance testing, etc.. Please refrain from forwarding resumes to the Talent Acquisition team or employees.
Join to apply for the Senior Manager, Regulatory Affairs role at Protara Therapeutics. The Senior Manager, Regulatory Affairs, supports regulatory strategy and operations for clinical stage programs, ensuring compliance with 21 CFR Part 11, and assisting with US and ex-US regulatory submissions, including IND submissions and health authority engagement.. At least 5+ years in Regulatory Affairs within biotech/pharmaceutical industry.. Successful track record with IND, NDA, MAA, ANDA, BLA submissions.. Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
This is an exciting opportunity to work in a diverse, talented, and committed group of people to advance the treatment for oncology patients and experience multiple facets of regulatory affairs in a dynamic, collaborative, and global cross-functional environment.. Support Regulatory strategists in coordination of Regulatory Submission teamwork and meetings (e.g., help to maintain resource plans, initiate intranet document workflows for review and approval, help to maintain submission timelines, and initiate document inventories in collaboration with the RA lead and Regulatory Operations Publisher). Collect Regulatory information to support QP product specification files. Coordinate archival of submission information and Regulatory Health Authority acknowledgment. Knowledge of the drug development process, drug laws, and global regulations and requirements is preferred
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS).. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.. The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs.. This role is based in Waltham, MA without the possibility of being fully remote.. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).