East Coast / Tri-State ** Senior Director / Regulatory Affairs – Lead a USD 5+ Billion Asset (Code USA 130221 )

Reference: MG130221

Expiry Date: 12-07-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

East Coast / Tri-State ** Senior Director / Regulatory Affairs – Lead a USD 5+ Billion Asset

My client is a prestigious top 5 bio-/pharmaceutical company with a stable of high value patient products, a large pipeline across multiple therapeutic areas, and an enviable reputation built over many decades. We are looking for a self-starter, who wants to be given a responsible role for leading Global RA Strategists (GRLs) on a very high value, well-known brand in solid tumor:-

  • This is the first ladder to executive leadership, the line manager has denoted you will be part of the extended leadership team, and will present to Governance
  • You will have to have managed between 5-7 people in some kind of direct line manager capacity or show you have exemplary people management skills
  • You will be used to working with high value assets in the type of lifecycle where you have complexity, so label expansions, new indications, protocols targeting subsets of segments, and many clinical studies exploring drug-drug combinations
  • The company has a Cadillac relocation, will postpone relocations until after Covid, and post-Covid offer a 50% 50% in time split, as a standard working policy post-Covid
  • This role is commutable post-Covid from PA, NYC, NJ, CT, north MD and DE based on the 50:50 split in home and office-based
  • The hiring process will be run over MS Team.

You will consider yourself a ‘high performer’, ‘compassionate and engaging’, you will love working in the Oncology tumor space and enjoy combining the strategic with the tactical, bringing science and regulatory together. You will be inspiring, know how to motivate people and enjoy working with your team. You will be interested in working for an organization which is pivoting to driving new molecules into your portfolio, in time you will transition to one of these.

The asset is high value, with >100 CS running currently with a global strategy team of 5-7 FTEs managing the global strategy for the brand, the USD amount in the title is understated. You will be taking on oversight for the GRLs and their plans, thinking and supporting through influencing and walking the corridors, to drive delivery via the extended regulatory teams for the strategies and plans. You will work with your own team of GRLs to shape and pressure test thinking, identify potential risks and benefits, and to drive innovation and the regulatory narrative. You will interface with senior stakeholders, above and beyond Governance, to smooth out any niches and bring consensus. You will be supported by the LT, who tend to think more in steady progress than big leaps. 

The senior LT is highly polished, have achieved a strong track record in their formative years, and know how to manage from groups of people by influencing and motivating. It’s a polished environment, there are world class support teams in publishing, labeling, CMC, and internationally. China is a core development market in addition to US, Europe and some selected countries, so the remit of this role is to provide oversight to all of these countries (in regulatory terms), support and attend as needed major health authority meetings (as a support to your GRLs) and deliver regulatory excellence in this regard, also to take over a couple of the seats in industry associations.

There is a lot in this role to keep you engaged and busy (and remember this role will prime you for the next level up) - however, the line manager is known for her compassion in terms of people having work/life balance, and during Covid has given large degrees of flexibility for employees with family to look after.  Please note, as I type these words from the line manager themselves, my client will give you the same level of support that her current LT receive and we accept these are challenging times for everyone - your new work ‘honeymoon’ period will be calibrated to these ideas we all face during Covid.

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!

To apply for this new role, please contact us, asking for Matt or Roland on US dial 908-332-9157 or 908-348-6717 – or send us a full CV in complete confidence to roland@advtalent.com or matt@advtalent.com. ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.

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