Expiry Date: 26-12-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Location: NJ/PA Borders
“I would describe this organization and the international regulatory strategy team as one of my most dynamic clients - they support a fast-paced and well-funded Oncology pipeline and Portfolio (including mAbs, Nibs, Cell and Gene therapy products) and work directly with the GRLs to develop international strategy that supports int’l majors and emerging markets!”
About The Role
We are happy to be presenting a Regulatory Affairs International / Intercontinental Strategy RA Lead working the regulatory strategy group that supports a well-known and expansive industry leading Oncology franchise (solid tumor and hemo).
The remit is to represent the Intercontinental Regulatory function across multiple Global Regulatory Strategy Teams, for products either in Phase 2B/3 and recently approved first filings and sNDAs, with you providing strategy and guidance for your regions, by working with the Global Regulatory Strategist as well as the affiliates and cluster teams to define strategy, executive submissions and support for your regions, health authority questions and responses.
This is the type of company where you can grow, develop and lead interesting and high-profile projects for molecules with strong data – and the leadership of this group is interested in giving as many opportunities as possible to diversify your skill set and develop your strategic experience.
About Your Experience
You will have wither specific regional experience including LatAm, AP, MENA, or international majors, for late stage development to filing (so some regional INDs, as well as MAAs) or have been submerged in large scale waived filings for MAAs or Line Extensions / New Clinical Indications.
You will enjoy the science of oncology, and be working in a matrix under a GRL where you have clearly defined remit and objectives, and in a company which has added a great deal of value to being present in the regions as quickly as possible in terms of time from first approval to international registration.
You will ideally have worked in Oncology or are willing to put in the time to learn more about Oncology, or blood cancers, in an area with continues to have high unmet medical need.
On offer is a great package including a very strong salary and bonus scheme, shorter vesting stock plan and a generous health and savings plan schemes. My client will consider covering losses on 2021 performance bonus on joining and also any loss of vesting stock for 2022/23).
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