Vice President, Regulatory Affairs.
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in a search for a Vice President, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides regulatory oversight and guidance to assure all health authority requirements are met.
- Provides regulatory support for all aspects of the development program.
- Is accountable for the development and submission of regulatory documents. Ensures timely, high-quality, and regulatory-compliant submissions.
- Advises internal development functions regarding regulatory impact of development decisions.
- Proactively identifies regulatory issues and provide solutions.
- Evaluates and pursues regulatory options that will lead to successful regulatory approval using expedited pathways.
- Maintains knowledge of the current regulatory environment.
- Serves as regulatory liaison with partners and regulatory agencies. Responds to requests for additional data, prepares internal teams for interactions with regulatory agencies, and negotiates directly with regulatory authorities regarding company filings.
- Contributes to the creation of overall product development strategy; monitor and deliver regulatory project plans throughout the lifecycle.
- Provides support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
- A Bachelor’s degree in relevant discipline is required. An advanced degree is preferred.
- Significant biopharmaceutical industry experience in regulatory affairs is required.
- Must have the ability to review, understand, and explain the regulations and guidance documents to guide project teams.
- The demonstrated ability to ideate, develop and implement regulatory strategies for product development programs is required.
- Requires proven experience with FDA submissions, IND to NDA.
- Experience managing and collaborating with outside vendors is required.
- The ability to collaborate effectively with internal and external stakeholders is required.
- Requires knowledge of regulations and regulatory processes in all global markets.
- Must have demonstrated experience interacting with regulatory authorities and cross-functional teams.
- Must be team-oriented with excellent communication and interpersonal skills.
- Must have strong prioritization and problem-solving skills with the ability to juggle multiple high priority projects and be flexible as new challenges arise.
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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