Featured Opportunity
Senior Director / Director Global Regulatory Lead
OUR CLIENT:
At a time where so many pharma/biotech companies are being hit hard, our client is growing and flourishing! When you want to know about the culture and workplace - look for examples. Nominated by local news in the Boston area as one of the “best places to work”, this only happens with great peer reviews. With a growing pipeline and a reputation of having some of the most incredible, innovative scientific approaches to unmet medical needs, they explore approaches to make precedent, not follow it. Embracing the best approaches of small and large molecules, the innovation begins with their scientists and ends with this Regulatory Group achieving approvals in unparalleled new frontiers.
At a time where so many pharma/biotech companies are being hit hard, our client is growing and flourishing! When you want to know about the culture and workplace - look for examples. Nominated by local news in the Boston area as one of the “best places to work”, this only happens with great peer reviews. With a growing pipeline and a reputation of having some of the most incredible, innovative scientific approaches to unmet medical needs, they explore approaches to make precedent, not follow it. Embracing the best approaches of small and large molecules, the innovation begins with their scientists and ends with this Regulatory Group achieving approvals in unparalleled new frontiers.
THE OPPORTUNITY:
The scope of this Global Regulatory Lead position is unique, and directly relates to the stature that the function of Regulatory holds within the organization. Regulatory is not a participant on the team, but a leader - focusing the direction and strategies that new science to partner with the Health Authorities across unmet medical needs that are also “first in class”. Because they are working mainly in large molecules, you can bring your background in small or large molecules and work with bright, broad-minded development teams open to new approaches. If you are going to work with innovative science, success only comes with intelligent and intuitive individuals working with inventive and persistent approaches to create new options for patients. With a global approach to all programs, regulatory’s pro-active and resourceful strategies are integral to the team’s success. Innovative science is what they have built their reputation on. If you are driven by a passion for exploring new pathways and defining precedent this could be an exceptional position for you. We all know there are many global regulatory positions, so what defines this from others? First and foremost the team and the friendly camaraderie that balances the hard work! With multiple opportunities in the portfolio, you will manage to gain an NDA or BLA approval, along with European approvals. If one program fails, not only do you still have the job security of working on another, but due to the innovative science, what you learned from that program’s failure leads to your success with the next program. Often companies are looking for someone who has already done ”XYZ”…here you can gain that expanded knowledge of different approaches that are marking milestones for the regulatory pathways your peers in other companies will be following and using as their standard in the future. They will truly follow your lead. All this and the opportunity to manage a small group if that is important to you!
The scope of this Global Regulatory Lead position is unique, and directly relates to the stature that the function of Regulatory holds within the organization. Regulatory is not a participant on the team, but a leader - focusing the direction and strategies that new science to partner with the Health Authorities across unmet medical needs that are also “first in class”. Because they are working mainly in large molecules, you can bring your background in small or large molecules and work with bright, broad-minded development teams open to new approaches. If you are going to work with innovative science, success only comes with intelligent and intuitive individuals working with inventive and persistent approaches to create new options for patients. With a global approach to all programs, regulatory’s pro-active and resourceful strategies are integral to the team’s success. Innovative science is what they have built their reputation on. If you are driven by a passion for exploring new pathways and defining precedent this could be an exceptional position for you. We all know there are many global regulatory positions, so what defines this from others? First and foremost the team and the friendly camaraderie that balances the hard work! With multiple opportunities in the portfolio, you will manage to gain an NDA or BLA approval, along with European approvals. If one program fails, not only do you still have the job security of working on another, but due to the innovative science, what you learned from that program’s failure leads to your success with the next program. Often companies are looking for someone who has already done ”XYZ”…here you can gain that expanded knowledge of different approaches that are marking milestones for the regulatory pathways your peers in other companies will be following and using as their standard in the future. They will truly follow your lead. All this and the opportunity to manage a small group if that is important to you!
To succeed here:
Location: Boston, MA area
- Be driven and motivated by incredibly innovative science
- Have a desire to expand your regulatory horizons and experiences. Think not just “outside the box” but stretch yourself to “define the box”!
- Be flexible! With innovative, new science comes the need to always try something new when one approach or program closes, take that knowledge to succeed in the next program
- A track record of successfully working with the FDA and global health authorities and wanting to take that experience to the next level
- Take your passion of regulatory affairs and communication skills to work with a very collaborative team and keep them steered on the best regulatory pathway for product approval success
Location: Boston, MA area
Contact us so we can share all of the details about this role to see if this is the best next step for your career.
Contact:
Lish Cook
Project Coordinator
Insigni Partners
Please contact us for more information.
Contact:
Lish Cook
Project Coordinator
Insigni Partners
Please contact us for more information.
