Expiry Date: 13-12-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Global Drug Development role in Oncology – Great Training – Excellent Package – Remote (with HQ in Greater Boston) – Unique Bio/Pharma with an exclusive MOA
Location: Remote, with offices in Greater Boston
We have a fabulous new opportunity to join this exciting clinical-stage biopharmaceutical company developing a novel class of medicines, with a focus on Oncology. Our client is based in Greater Boston but is offering this position as remote for those experienced in regulatory development US and/or EU).
You will like this role if:
Our client is quite unique from other biopharmaceutical companies, their success is driven by their great people an inclusive culture, and an innovate MOA and development platform which has resulted in multiple successful collaborations with other major Biotech companies across many therapeutic areas, leading to huge levels of excitement across the industry for the potential of their products.
They continue to rapidly expand and grow and are now recruiting for a Senior Manager of Regulatory Affairs, to lead/support the development and execution of regulatory strategies for assigned Oncology programs in development, in a role covering both US and EU projects, and reporting into a highly experienced Senior Director of Regulatory Affairs (Head of Regulatory Affairs), offering great training and mentoring.
This will be a varied role covering all aspects of regulatory development for US and EU markets, managing the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned programs/projects, which may include some strategic submissions such as INDs, CTAs, pediatric applications, orphan drug designations, attending meetings with regulatory agencies (FDA, EMA), and leading cross functional teams in preparation of regulatory submissions.
On offer is very competitive package at Senior Manager grade, including a strong basic, bonus and stock, with the opportunity to work remotely or if you prefer, from offices in Greater Boston. This role also comes with great training and a career pathway to Associate Director grade and Global Regulatory Liaison responsibilities.
To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714 or send us a copy of your resume to email@example.com. We will support you throughout the interview and on-boarding experience.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.