SEC Recruitment

Regulatory Affairs Manager

Location
Homeworking
Salary
£98421.16 - £102522.04 per annum + 30 days vacation and other bens.
Posted
28 Apr 2021
Closes
26 May 2021
Ref
126719
Contact
John Spring
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Regulatory Affairs (RA) Manager (Home-Based in the US)

This is a fantastic opportunity to join one of the world's leading CAR-T oncology companies with a strong pipeline of cancer cell therapy treatments. The role is a key hire for the business, leading all US based regulatory strategies and providing guidance on regulatory CMC, nonclinical and clinical projects.

Salary & Benefits:

Up to $125k + excellent benefits, including up to 30 days' vacation in line with the European HQ.

Role and responsibilities:


* Act as the RA Lead for assigned CAR T cell pipeline projects
* Development and implementation of global regulatory strategies, communicating effectively with internal and external stakeholders
* Act as a guide CMC, Nonclinical and Clinical topics
* Development of detailed project plans and timelines, identifying critical path activities, risks and gaps
* Management of regulatory submissions and rapid responses to Health Authority questions in line with appropriate timelines
* Liaise with SMEs, developing key messages and completing regulatory submission documents
* Writing, preparing and reviewing scientifically sound regulatory documents
* Ensuring the regulatory submission documents are accurate, consistent and complete in line with regulatory authority requirements
* Formatting of submission-ready documents to meet eCTD publishing requirements
* Review and interpret regulatory, clinical, scientific and other technical documents
* Represent RA Department at team meetings as assigned
* Represent Company as RA liaison with Health Authorities
* Mentor RA staff and cross-functional team members
* Contribution to new internal documentation and SOPs

Requires skills and qualifications:

* Masters in Life Sciences 5+ years' experience in a biopharma regulatory role or PhD in Life Sciences with minimum 3+ years' experience in a biopharma regulatory role;
* Expertise in Immuno-Oncology/CMC CAR-T Cell Therapy preferred;
* Experience in eCTD-compliant regulatory submissions;
* Experience working within a Quality Management System (GxPs);
* Knowledge of European, US and International laws, regulations and guidelines for biologics and human cells and tissues

This opportunity is a key role in a fast-growing cell therapy company who have a fantastic pipeline of CAR T oncology products. You will be a leader in the US as the company continues its global growth and the role offers a combination of excellent career development, great product exposure and a superb package and benefits.

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650

Apply for Regulatory Affairs Manager

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs