REMOTE ** Regulatory Affairs US Liaison for Oncology ** Snr Mgr or AD ** Early Stage Dev. ** A great opportunity to take on more strategic responsibility!

Reference: EBT519E

Expiry Date: 17-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

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Job Description

We have a new role open for a strong and confident Regulatory Affairs professional to operate as the US Regulatory liaison, initially for early stage development assets in Oncology, but with the intention that you grow your experience to lead further activities as the indications move through the pipeline to NDA/MAA. The position is graded Snr Manager, but my client will consider those who also feel ready to move into their first Associate Director role. This is a great opportunity to be mentored and encouraged to take on more strategic responsibility.

Location: HQ based in Cambridge, MA but the role can be fully remote.

My client is a clinical-stage biopharmaceutical company developing a novel class of medicines. They are a young organization but have recruited a number of established leaders in Regulatory, Clinical and Medical and have an exciting pipeline of oncology indications, offering potentially life changing treatments for a wide range of cancers. Their product has a unique method of action, which is recognized in the industry as a potential game changer, resulting in a number of top ten biotech companies collaborating on a number of wider uses, across a number of other major therapy areas.

The regulatory team here is growing, and they are seeking an adaptable and strategic thinker with the ability to generate creative solutions to complex problems, who can identify different and novel ways to find answers. Initially you will start as the Regulatory Affairs Liaison working in early-stage clinical development (Phases 1&2) reporting into a highly experienced Head of Regulatory Affairs, who is personally offering you “a great opportunity to be mentored and encouraged to take on more strategic responsibility!”.

The role will grow in challenges and responsibilities to move from regional liaison to global liaison, to go from early development to late development/registration, and to move from supporting activities to leading your own programs. You will need to show that you are highly collaborative and can build strong relationships with internal and external partners, with a high level of integrity and then the next step will be to move into a key position around NDA/BLA’s in a global leadership role overseeing assets for both the US and EU regions.

Activities:

  • You will be responsible for the development and execution of regulatory strategies for assigned early development programs or projects, including development and maintenance of the Regulatory Plan, working with the Head of Regulatory Affairs and other colleagues as appropriate
  • Managing 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 or orphan drug and fast track applications
  • Supporting preparations and attending regulatory authority meetings for assigned development programs, potentially as the primary contact with Health Authorities

Qualifications:

Ideally you will have some knowledge in supporting interactions with health authorities, including US FDA, and be familiar in key regulatory pathways for product development, for example pediatrics, orphan drugs, Regulatory Agency advice, expedited development (e.g. Fast Track, Breakthrough Designation, PRIME). Therapeutic experience in oncology is desirable but not essential, as is experience of working in early development.

 

If you are interested in a role where you will be encouraged to take the lead and make an impact  through collaborating and driving development, then call me Theo Moore or Roland Schnapka today on 908.348.6714 or email us via CV@AdvTalent.com and we will immediately respond to your application with more information on this role.