Director, Global Regulatory Affairs
Description
DIRECTOR, GLOBAL REGULATORY AFFAIRS – ONCOLOGY LEAD
- Growing $5Bn+ Pharma with Great Culture
- New York City (hybrid)
- RETAINED SEARCH
Cornerstone Search Group has been retained again by a profitable and stable European pharmaceutical company with rising revenues, prides itself on a work environment that reflects its country’s renowned culture, has a healthy multi-billion dollar market cap, and recently set up in New York City its first US-based R&D hub. With a product portfolio featuring a recent oncology blockbuster still on the ascent, and the upcoming launch of another anticipated oncology blockbuster, this company is in a very active phase of building out their clinical pipeline through both in-house research and in-licensing efforts. This hybrid role will lead US and global regulatory activities in their Oncology therapeutic area, serve as the regulatory expert on cross-functional product development teams globally, work with JV partners, and serve as the US-based point of communications with the FDA on their product portfolio. You will report to a highly experienced and down-to-earth Regulatory Affairs Department Head and have regular interaction with their very accessible senior management team. Our client is seeking an entrepreneurial and experienced oncology regulatory affairs professional who will be excited to also help grow their new US presence, values working with like-minded high EQ, GTD people in a high collaboration and low bureaucracy environment, and somebody who has a passion for drug development but not at the expense of work/life balance.
WORK AUTHORIZATION: Our client will consider candidates who require an H-1B transfer, TN-Visa, or equivalent, as well as Green Card / Permanent Resident sponsorship.
Location
LOCATION: New York City (on-site or hybrid)
Our client is focused on hiring the right person rather than the right location, so they will consider candidates who require a limited on-site arrangement or even a hybrid work arrangement. They can offer relocation assistance as well.
Features
5 ATTRACTIVE FEATURES:
- Uniquely attractive opportunity to join a growing, profitable, publicly-traded company with a multi-billion dollar market cap that still retains a small company feel with very few layers.
- Our client’s marketed products include a fast-growing cancer blockbuster, and their lead clinical candidate is in Phase III and is anticipated to also become a blockbuster. Our client has a long-term focus in Oncology and CNS / Neurology and has a proven history of discovering and developing multiple drugs that have been marketed in the US by multiple “Big Pharmas”. Our client is now focused on taking the next step in their growth to become a globally integrated pharma.
- This company takes pride in its culture, reflecting its country’s heritage as having one of the world’s most positive populations.
- You will share in the responsibility to shape the future of the company’s presence in the US, which was only recently established.
- We have partnered with this client multiple times before, so we know them quite well. The people that we have helped them hire have been very happy with the culture and impressed with executive management and their peers.
Responsibilities
RESPONSIBILITIES in a NUTSHELL:
- Develop and execute US and global regulatory submission strategy for oncology assets, including an exciting potential first-in-class (pathway) molecule.
- Interact with the FDA and global regulatory authorities.
- Take responsibility for the preparation and content of regulatory dossiers/documents (e.g., INDs, CTAs, BRD/Scientific Advice Requests, and NDAs/MAAs).
- Ensure that product development programs are aligned with US and global commercial strategy.
- In addition to the company’s wholly owned assets, interact with other pharms on JV-partnered assets.
- Lead internal company forums for the sharing of best practices and lessons learned related to US regulatory activities.
- Stay on top of emerging issues that may impact regulatory product strategy and adjust accordingly. Assess scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines in order to make recommendations.
Qualifications / Requirements
DESIRED SKILLS/ QUALIFICATIONS / EXPERIENCES / BEHAVIORS:
- 5-10 years of pharma/biotech company Regulatory Affairs experience, with an emphasis in Oncology clinical development reg affairs activities, including the IND process and ideally also NDA/BLA filing experience.
- Demonstrated experience with defining and leading regulatory strategies.
- In depth working experience of US regulatory affairs, including FDA interaction experience, coupled with at least a solid understanding of EU, ICH, and other global requirements.
- Experience with preparing, reviewing, and submitting FDA Clinical modules. CMC and Nonclinical module experience would be a plus.
- Operational experience with regulatory submission to the FDA (e.g., INDs and NDAs). It would be a plus, but not a requirement, to have EU submission experience (e.g., CTAs and MAAs) or other global regulatory submission experience.
- Experience with novel or expedited regulatory pathways would be a plus but is not required.
- Seeking a proactive, self-motivated, and entrepreneurial individual who has the ability to prioritize and get things done.
- Seeking a biotech mindset - someone who is innovative in their approach, intellectually inquisitive, has a flexible personality, and is highly collaborative.
- BA/BS required.
*PLEASE NOTE*: For high potential individuals who may not have enough of the experiences sought, our client will consider candidates at the Associate Director level.
Contact
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