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. Telecommuting accepted. Mail CV to KPTI, attn: Jennifer Luo, 85 Wells Ave.,...

Sr Associate, Regulatory AffairsKaryopharm Therapeutics, Inc., a commercial-stage pharmaceutical company, seeks a Sr Associate, Regulatory Affairs to manage regulatory submissions, publish and prepare submission documents, and track regulatory filings. The ideal candidate will have proficiency with eCTD tools and processes.Key Responsibilities:Manage...

Job Title: Sr. Regulatory Affairs SpecialistTeleflex is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our Global Operations organization, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...

Job Title: Sr. Manager, Regulatory AffairsThermo Fisher Scientific is seeking a highly experienced Sr. Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies for product approvals and compliance in the US and Canada.Key...

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,...

Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a seasoned professional to fill the role of Director, Global Regulatory Affairs, Development Strategy for a leading global biotechnology company.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful...

EMPLOYER: AstraZeneca Pharmaceuticals LPTITLE: Associate Regulatory Affairs DirectorLOCATION: Gaithersburg, MDHOURS: Full-Time; Mon-Fri (40 hours/week)DUTIES: Lead the end-to-end planning, coordination, and execution of assigned deliverables. Contribute to regulatory submission strategy, identifying submission risks and opportunities. Lead regulatory...

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...

Job Title: Regulatory Affairs AssociateAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.We are seeking a highly motivated individual to provide support to global regulatory activities in obtaining worldwide approvals to...

Job Title: Director of Regulatory Affairs CMCWe are seeking a highly skilled and experienced Director of Regulatory Affairs CMC to join our team at GSK. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the timely and successful submission of CMC regulatory documents to support the development,...

What You Need to Know About Regulatory Affairs SpecialistExample of Regulatory Affairs Specialist Job: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.Regulatory Affairs Specialist Responsibilities ...

Duration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.

Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...

Job Title: Director of Quality and Regulatory AffairsProcom Services is seeking a seasoned professional to fill the role of Director of Quality and Regulatory Affairs. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our products and services.Key Responsibilities:Quality Management: Develop and implement...

Job Title: VP, Quality & Regulatory AffairsStratasys is seeking a highly experienced and skilled VP, Quality & Regulatory Affairs to lead all aspects of quality assurance and regulatory compliance across the Global Enterprise.Key Responsibilities:Develop and implement a comprehensive quality strategy that aligns with the company's goals and...

Job Title: Head of Global Labelling - Regulatory Affairs Job Type: Full time permanent position Locations: UK, France, Germany, Ireland, Netherlands, Norway, and the United States of America (Remote) Remuneration: Competitive salary and benefits packageWorking for one of the industry's leading pharmaceutical companies, this is a fantastic opportunity to...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA’s deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is responsible for supporting a variety of activities in the department related to regulatory submissions and R&D...

A company is looking for a Director of Regulatory Affairs, Lifecycle. Key Responsibilities Oversee the Lifecycle Regulatory team and manage personnel activities Develop and execute global regulatory strategies for commercialized products Ensure compliance with regulatory Conditions of Approval and oversee advertising and promotion reviews Required...