Job Description

“New opportunity to join an expanding Global Biotechnology company and advance your career by continuing to grow and develop your expertise in US and Global development activities from Phases II through to BLA - taking a leadership position for Scientific advice meetings, PiPs and ODD’s.”

This role will give you the chance to:

• Lead US and Global development activities from Phase II through to BLA
• Take a leadership position for Scientific advice meetings and HA interaction
• Lead the strategy/HA interaction/filing for your project
• Be mentored by a number of highly successful GRL’s based in RTP and Atlanta who all graduated from this exact position
• Continue to develop your expertise in a role that could lead to opportunities for line management or team leadership in the future.

We have a new opportunity for an accomplished Regulatory Affairs professional to join an expanding Global Biotechnology company in a role with direct and growing strategic responsibility for US and Global development projects from Phase II through to initial BLA.

The position can be based at their offices in either RTP and Atlanta where the organisation is going through a strong stage of expansion of both its products in development and the number of products due to go to registration in the next 18 months, all within a culture that is still based on individual achievement mixed with team goals. 

With their focus on natural, long-term growth, this amazing organisation depends on the contributions of talented and committed professionals like you who are determined to drive through progress. In turn, they make sure your work environment leaves you the space you need to attend to your personal goals, meet your family obligations, and pursue your professional development. Working at this organisation means working at the forefront of innovation. Over the years, they have often engaged in new market trends…or even set them...!

For this role it’s essential to have experience in US NDA/BLA/Line Extensions or any of the following: IND’s, PiPs, ODD’s, Scientific Advice, preparing briefing packages. In return you will receive a strong and very competitive salary, high level bonus, fully comprehensive healthcare package and a brilliant re-location package with a sign-on bonus and support from a certified re-location team.

Please contact Theo Moore on US +1-908.348.6714 or via email at Theo@Advtalent.com and I would be happy to discuss the role further and give you more information.

If this role isn’t quite for you but you are open to something new, I would welcome to discuss other roles we have open.

To Apply!

To apply for this role, please contact me Theo Moore on US 908.348.6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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