Vice President, Regulatory Affairs
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Vice President, Regulatory Affairs.
Major tasks and responsibilities include:
- Directs and coordinates regulatory activities and works with both the project team and the executive team in formulating strategy and overseeing global regulatory submissions.
- Interprets regulatory requirements and feedback, and administers policies relevant to the critical functional area.
- Leads and builds both the regulatory and quality functions including hiring, managing, and developing personnel.
- Acts as a key member of the project team and provides input into development plans.
- Serves as point of contact and represents the company before regulatory authorities, including preparing meeting agendas, materials, minutes, and interpretations of regulatory correspondence.
We seek candidates with the following qualifications
- Ensures both ongoing compliance and audit readiness within the R&D organization.
- Oversees development and refinement of regulatory and quality policies, procedures, and SOPs within the corporate infrastructure context.
- Monitors the competitive regulatory environment and informs the leadership team accordingly.
- A BS in biological or physical sciences is required. An advanced degree is preferred.
- Must have 12+ years of regulatory experience.
- A proven track record of working in a cross-functional team environment representing the regulatory function, including experience with FDA, EMA and global regulatory authorities is required.
- Requires deep familiarity with the drug development process and experience with biologics.
- Regulatory experience with nephrology or rheumatology related clinical indications is required.
- Must have mid and late-stage development experience and NDA/ BLA/ or MAA preparation and submission experience.
- Must have the ability to work in a small to mid-sized company within a largely virtual environment.
- A willingness to work in a fast-paced start up environment is required.
- Requires strong leadership, management, and mentorship skills.
- Must be adept at formulating and driving strategy, but also playing a hands-on role in regulatory submissions.
- The ability to think and manage strategically, with attention to detail and a sense of urgency is required.
- Must have strong communication skills, both written and verbal, with a proven track record of working with and presenting to the executive management team, board members and external thought leaders.
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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