Director, Regulatory Affairs
Our client is a biotechnology company specializing in synthetic biology. They have asked us to assist them in a search for a Director, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Serves as the Regulatory Lead on product teams.
- Works collaboratively with cross-functional teams to resolve complex project issues.
- Provides regulatory strategy and guidance to global product owners and project teams.
- Makes recommendations to shape the global strategy in line with regional and commercial objectives.
- Demonstrates regulatory expertise and extensive knowledge of regulatory requirements and regulations.
- Ensures planned development activities compliant with US and global regulatory guidelines, and a critical analysis of risks and issues.
- Ensures that teams are provided with regulatory advice and intelligence to assist planning and issue resolution during product development.
- Authors and prepares regulatory with input from relevant stakeholders and subject matter experts.
- Develops and advises project team on regulatory strategy and implementation processes for various program activities.
- Ensures documents for regulatory submissions align in quality, compliance, technical merit, and strategy.
- Serves as a regulatory liaison to Health Authorities, with the expectation to develop, foster, and maintain a professional relationship.
- Maintains clear communication and professional relationships with functional areas inside and outside the regulatory space.
- Interacts with outside vendors, suppliers, contract research organizations, and others, as appropriate, to manage regulatory activities.
- Critically reviews complex reports and validations for scientific merit and regulatory suitability.
- A Bachelor’s degree in a scientific field is required, an advanced degree is preferred.
- Must have a minimum of 8+ years of relevant regulatory affairs experience in the pharmaceutical or biotechnology industry.
- Extensive experience in interacting with Health Authority personnel is required.
- Experience in implementing successful regulatory strategies with US FDA is required.
- Must have excellent analytical thinking and problem solving skills as well as excellent written and verbal communication skills.
- The ability to work well independently and with others is required.
- Requires the ability to handle multiple projects simultaneously and maintain flexibility.
- Must be computer literate with excellent knowledge of company systems for electronic storage and submission.
- Experience with Adobe Acrobat, MS Excel, MS PowerPoint, and MS Word, and the ability to learn new computer programs is required.
- Must have the ability to understand and use technical documents, such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.
- Requires the ability to thrive and contribute to areas with undefined regulatory pathways.
- In-depth knowledge of US pharmaceutical regulations and prior experience with biologics is required.
- Must have the ability to function in a controlled environment regulated by FDA and to handle confidential data.
- The ability to meet deadlines, take initiative, and make decisions within department and company guidelines 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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