Sr Associate, Regulatory Affairs

Sr Associate, Regulatory Affairs Sr Associate, Regulatory Affairs sought by Karyopharm Therapeutics, Inc., a commercial-stage pharma co in Newton, MA: Manage reg submissions, publish and prep submission docs, proficiency with eCTD tools and processes, track regulatory filings, etc.All potential applicants are encouraged to scroll through and read the...

JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway,...

Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Job SummaryMedtronic is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning and executing regulatory strategy for molding and capital tooling projects, assessing the regulatory impact of post-marketing changes, and leading project teams...

Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

Regulatory Affairs Associate I External ID # Fremont, CA - ON SITE 22 month W2 contract (with potential to extend or transition to perm) Pay rate: $30-35/hour - Depending on Education and Experience Summary: Shift: 1st Shift: Mon-Fri, 8:00AM-5:00PM Responsibilities:Assist in preparing responses to global information requests and related maintenance...

Quality and Regulatory Affairs LeaderRapiscan Systems is a leading provider of detection technology, offering cargo and vehicle inspection systems and services for various industries. We strive to deliver best-in-class imaging, high reliability, and operator satisfaction to our customers.The Vice President of Quality and Regulatory Affairs will play a...

Regulatory Affairs CoordinatorCity: FriscoState: TexasZip: 75034CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Coordinator. As the Regulatory Affairs Coordinator, you will be responsible for assisting the Regulatory Affairs team with gathering and organizing documents for...