Director, Senior Global Regulatory Lead
Our client is a global biotherapeutics company. They have asked us to assist them in a search for a Director, Senior Global Regulatory Lead.
Major tasks and responsibilities include:
- Serves as a regulatory leader who crafts and drives development of scientifically sound, prospective, global regulatory strategies for a product portfolio.
We seek candidates with the following qualifications:
- Represents the global regulatory affairs team on product strategy teams.
- Leverages team members to achieve regulatory deliverables.
- Acts as a decision maker for the team as needed, as well as assesses and communicate regulatory outcomes and fosters reviews and discussions.
- Approves project related deliverables for the team.
- Contributes to respective product portfolio teams and articulates sound regulatory input and perspective into product strategy.
- Oversees the product portfolio by delivering global regulatory submissions throughout development, including collaborating with respective regulatory project manager to ensure timely delivery.
- Leads global regulatory project deliverables and mentors team members.
- Supports the global regulatory affairs region in product portfolio health authority interactions globally.
- A Bachelor’s degree in a scientific field is required, an advanced degree is preferred.
- Must have 12+ years of biotech/pharmaceutical industry experience, and 8+ years of regulatory experience, including 5+ years in development.
- Agency interaction experience is required, ICH regions are preferred.
- Clinical regulatory experience and exposure to market access activities is preferred.
- Must be able to lead without authority.
- Requires the ability to assess product vision and apply a regulatory lens to assess opportunities and risks.
- Must be able to build and works effectively across cultures and seek out alternative perspectives when assessing potential outcomes.
- Prior experience mentoring junior staff members in regulatory affairs is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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