Manager of Regulatory Affairs Cmc

Biopharmaceutical, regulatory affairs, senior management, CMC, permanent job, oncology, hybrid. **What you'll need to succeed**You will need to have had significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience; experience in the preparation of CMC components of MAA or post-approval submissions for small molecule...

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Company DescriptionBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short...

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic...

The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy and...

Regulatory Affairs Consultant Fully Remote 3-6 Months Hourly Rate Qualifications/Skills Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner. Below a very top-level list (can...

Regulatory Affairs Consultant Fully Remote 3-6 Months Hourly Rate Qualifications/Skills Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner. Below a very top-level list (can...

The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy...

Job Title: Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.The ideal candidate will have extensive...

Job DescriptionBicycle Therapeutics is a pioneering pharmaceutical company developing innovative medicines for underserved diseases. As Associate Director, Regulatory Affairs CMC, you will play a pivotal role in shaping the regulatory strategy and submissions for our assigned programs or projects.Key ResponsibilitiesDevelop and execute global regulatory CMC...

The Head (Senior Director) International CMC Regulatory Affairs reports to the Executive Director, International Regulatory Strategy and is accountable for leading a team of regulatory professionals (7-10 direct reports at Director level and 30-40 indirect reports) responsible for strategy, delivery, and execution of international CMC Regulatory strategy...

Job DescriptionWe are seeking an experienced Regulatory Affairs Consultant to join our team at LennTech Search. This is a fully remote position that requires 3-6 months of commitment with an hourly rate.Key ResponsibilitiesProvide regulatory support to the O1 Device Development (DD) team, including final review, comment, and approval of device-related...

Gilead Sciences, Inc. is seeking a highly motivated and experienced Senior Associate, Regulatory Affairs CMC to join our team.Job Requirements:Minimum 3 years of experience in Regulatory Affairs CMC or relevant pharmaceutical industry experience.Knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional...

CK Group are recruiting for a CMC Regulatory Associate Director to join a company in the Pharmaceutical industry on a contract basis for 12 months. **Salary**: Per Day £400 PAYE OR £520 Umbrella, this role is inside IR35 **Company**: Our client is a global research-based bio pharmaceutical company with a major UK presence who are committed to making a...

**Overview of the Position:**Gilead Sciences is seeking a Senior Associate, Regulatory Affairs CMC to provide regulatory support for new marketing applications and post-approval regulatory filings across international regions.The successful candidate will work closely with Pharmaceutical Development, Analytical, Manufacturing and QA teams to assist and...

About the OpportunityWe have an exciting opportunity for a Senior Associate, Regulatory Affairs, CMC who is passionate about advancing therapeutics against life-threatening diseases. In this role, you will provide CMC regulatory support for new marketing applications and post-approval regulatory filings across international regions.As a key member of our...

Walker Cole is searching for a CMC Project Manager to join a clinical stage biotechnology company specialising in small molecules. As a CMC Project Manager, you will be responsible for providing chemistry and manufacturing support to expand the preclinicaland clinical asset portfolios. Role responsibilities include: - Technical CMC oversight for chemistry,...

About the RoleWe are seeking an experienced Regulatory Affairs Consultant to provide support for various projects, including device development and CMC activities. The successful candidate will have experience in regulatory affairs, particularly in the medical device and pharmaceutical industries, and possess strong knowledge of regulations and guidelines...

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Cambridge on a on a contract basis for 12 months. **Salary**: Hourly: £45.56 PAYE or £60.35 Umbrella Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering,...

At Gilead Sciences, Inc., we're seeking a highly experienced Regulatory Affairs Manager to lead our Global Regulatory team in the development and implementation of regulatory strategies for our Therapeutic Area (TA) portfolio. This role will oversee the preparation and submission of regulatory documents, as well as ensure compliance with global...

About GileadGilead Sciences, Inc. is a global biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We're looking for talented individuals to join our team as Regulatory Affairs Manager.Job DescriptionThis role will act as the Regional Regulatory Lead on complex or multiple products, compounds, indications or...