Regulatory Affairs Manager

Job title : Regulatory Affairs Manager
Location : Massachusetts, USA
Job type : Permanent
Salary : US$120000 - US$125000 per annum + 30 days vacation and other bens.
Contact name : John Spring
Contact number : +44 (0) 207 255 6650
Contact email : john.spring@secpharma.com
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