Regulatory Affairs Due Diligence Manager

Global Regulatory Affairs - Due Diligence Manager / Senior Manager
Your new company
This US Biotech are looking for a Regulatory Affairs professional with strong Due Diligence experience to join an exciting, high-profile project, this is initially a 6 month contract but has scope for extension. There is the option to be fully remote.
Your new role
As the Regulatory Affairs Specialist, Due Diligence, you will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL). As a member of a diligence team, you will be responsible for contributing to the diligence on behalf of regulatory affairs and will be empowered to seek optimal strategies and challenge assumptions to meet in-scope objectives and milestones. You will be responsible for the assessment of information that will lead to a regulatory recommendation. In addition, you may be an assigned regulatory representative for a product/s within a therapeutic area. In this case, you will identify and assess regulatory risks associated with product development and define strategies to mitigate risks in alignment with the global business strategy.

You may represent the company to the FDA or EMA as well as to corporate partners.

What you'll need to succeed

My client is looking for someone with strong Regulatory Affairs experience, from early to late stage development and maintenance and ideally those with rare disease experience.
What you'll get in return
Good hourly rate, fully remote working available, the opportunity to be part of a high-profile special projects team

What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply for this advert.
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