Expiry Date: 12-07-2021
Category Regulatory Affairs
Job Type: Full Time
US Tri-State ** Global Regulatory Leader **Lead highly promising MM asset out of P2 to filing!
My client is a prestigious top 5 biopharmaceutical company with a stable of high value patient products, a large pipeline across multiple therapeutic areas, and an enviable reputation build over many decades.
We are looking for a self-starter, who wants to take the hotseat, as Global Regulatory Leader for a Ph 2 asset with highly promising existing data, in a role where you will lead RA strategy and filings, with oversight for the key regulatory milestones for a MM NME:-
You will be hungry to find a NME and project which can catapult your career. If I look at the role and who it reports to, you can see how my client values merit, as the hiring manager did this type of role for some time, before being promoted twice to their current level, based on their passion, filings, and approvals.
What I like about the role is really twofold: the asset and the team.
It is part of a hematology regulatory group with a run of successes in the last 15 years, and is seeking to push the boundaries of haemo treatment both in terms of treatment options and survivability. The GRL role at this company has a lot of visibility, is embedded in the project team, and works hand in hand with stats and clinical, under the guidance of the line manager, who tends to manage form behind or as a facilitator to help the team identify and evaluate new ideas and approaches. The individual has a good reputation for building their people up!
You will be responsible for further developing the inherited RA strategy, steering and aligning with the EU, US and China RLs and for leading the sub-teams for INDs and the NDA core dossier, HA briefing packs, major responses to HA queries, any potential request for any type of accelerated or adaptive pathway, and of course, the HA meetings, EOP2, Pre-Sub, Review, etc.
Package & Relocation (if required)
In return you will receive a high-end package, a strong incentive stock and performance plan, and a relocation which can be stop watched til safe to move. The relocation is very strong, for house sale and purchase costs, as well as for renting if needed. My client will buyout stock, pension differences as well as lost bonus from leaving your current company.
To apply for this new role, please contact us, asking for me, Roland on US 908-348-6717 or my colleague Matt, on 908-332-9157 or send us a full CV in complete confidence to firstname.lastname@example.org and I will reply by return. ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.
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