May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.

It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA.Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.

Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.

The Sr. Regulatory Specialist, LATAM will prepare and submit regulatory compliance documents with regulatory authorities, and advise on regulatory affairs that stem from the U.S. Company's activities in the Latin American (LATAM) region.

The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.

Molecular Sciences in Seeds Regulatory Sciences team is currently seeking a (Sr.) Research Scientist/Molecular Subject Matter Expert (SME) in Molecular and Functional Genomics to support product development in biotech through regulatory safety studies.

RESPONSIBILITIES:The IT Sr Manager, Technical Product Manager for Regulatory Excellence combines modern Information Technology (IT) expertise, and knowledge of the pharmaceutical development business to transform the way IT is applied in Regulatory Affairs with a focus on systems unifying the processes related to Regulatory Operations and the overall user experience of our business customers.

15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.

The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.

Minimum of 10 years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry. We are seeking a highly experienced and strategic CMC Regulatory Affairs professional to join our growing team.

Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.

A strong understanding of molecular biology techniques for analysis of gene therapy products: to include (but not limited to) PCR, Infectivity, Potency, and various ELISA methods. In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV analytical testing and documentation for submission to regulatory agencies.

Cititec Talent has partnered with a boutique commodity trading company who looking to bring a Regulatory Reporting Specialist into the business to lead their regulatory reporting consolidation efforts, as they streamline their regulatory reporting solutions for Dodd-Frank and EMIR compliance.

The primary responsibility will be to interpret and report clinical cases in molecular diagnostics and assist the Division Director with assay design, feasibility studies, and clinical validation consistent with all regulatory guidelines (CAP, CLIA, FDA.

Jr. Specialist Cell/Molecular Biologist. To have 10 or more years of experience working as a Cell/Molecular Biologist engaging in cryogenic or room temperature correlative light and electron microscopy (CLEM) research in mammalian cell culture, molecular biology.