Senior Manager, Global Regulatory Affairs - Oncology Drug Development role – Great Training – Excellent Package – Remote

Reference: EBT519C

Expiry Date: 13-12-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
Съединени щати
Remote Working

Apply for position

Job Description

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:

  • You want to work (or continue to work) in Oncology development
  • You want to receive training, support and be mentored by a highly experienced Head of Regulatory Affairs
  • You want to provide input to a Global Regulatory Lead on the Regulatory Strategy Plan from a US perspective
  • You want to gain Global Development experience (to include the EU)
  • You want to work in a company where you can make an impact
  • You want to work in an expansive role, in a smaller team with higher levels of responsibility, visibility and autonomy!

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.

Responsibilities:

  • Responsible for the development and execution of regulatory strategy for assigned programs or projects, including development and maintenance of the Regulatory Plan, working with the Head of Regulatory Affairs and other colleagues as appropriate
  • Collaborate with external regulatory and quality consultants, and external organizations, to support the timely execution of regulatory submissions, responses to questions, audits and inspections
  • Manage the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned programs or projects, which may include some strategic submissions such as INDs, CTAs, pediatric, orphan drug designations, fast track approvals etc.
  • Monitor the regulatory landscape to anticipate and adapt to changes that may impact assigned programs or projects
  • Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy assigned programs or projects
  • Operate as the Global/Regional Regulatory Lead for assigned development programs
  • May serve as primary contact with Health Authorities (HA) &/or external collaborators globally for assigned programs or projects
  • May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
  • May support preparations and attend regulatory authority meetings for assigned development programs

Experience needed:

  • Bachelor’s degree in a scientific field or post-graduate degree preferred
  • Demonstrable experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
  • Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
  • Experience and knowledge in preparation of INDs, CTAs, or regional equivalents
  • An understanding of the drug product lifecycle from discovery to clinical trials to marketing application

 

To Apply!

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 cv@advtalent.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.