Vice President, Regulatory Affairs
Our client is a clinical-stage oncology company. They have asked us to assist them in their search for a Vice President, Regulatory Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Provides regulatory oversight and guidance to project teams to assure all health authority requirements are met and registration is successful using expedited approval processes.
- Evaluates aggressive regulatory options in pursuit of successful regulatory approval using expedited pathways.
- Holds accountability for the development and submission of regulatory documents (e.g., pre-IND and end of phase briefing books, INDs, IDEs, NDA/BLAs, CTAs, MAAs, responses to regulatory inquiries, annual reports, safety updates, etc.)
- Facilitates problem-solving and drive the overall regulatory strategy with project teams based upon the preclinical, clinical, and CMC development.
- Collaborates with other functions to strategize and implement an effective regulatory strategy in alignment with the overall clinical plan.
- Manages the regulatory strategy including effective communication with project teams and external partners.
- Effectively communicates the regulatory strategy, risks, mitigations and overall plans to the project teams and Executive Leadership team as required.
- Establishes and maintains relationships with regulatory agency representatives.
- Responds to requests, organizes and manages meetings with global health authorities, and prepares internal teams for these interactions.
- Negotiates directly with regulatory authorities regarding company filings.
- Oversees or outsources regulatory operations to assure timely publishing of all regulatory submissions.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Oversees GX processes and compliance in the company.
- Builds a regulatory and quality organization.
- Bachelor’s degree in a scientific discipline required. PharmD or PhD highly preferred.
- Must have a minimum 10 years in regulatory strategy managing oncology programs in the life sciences industry.
- Quality assurance experience is preferred
- Requires knowledge of the current US, EU, and Japanese regulations.
- Experience with CTD format and content for regulatory filings required.
- Requires a solid track record of securing oncology product approvals with successful NDA/BLA and or MAA.
- Requires experience maintaining a complex portfolio.
- Requires knowledge of and broad experience with regulatory procedures and legislation for drug development product registration, line extension and license maintenance in Europe and the United States.
- Must have familiarity with Fast Track, Orphan Drug and Breakthrough designations and application process.
- Requires experience managing complex schedules and priorities in dynamic environments, and the ability to conform with shifting priorities, demands, and timelines through analytical and problem-solving capabilities.
- The ability to communicate effectively both orally and in writing, both internally and with external vendors and partners is required.
- Must be familiar with e-publishing systems for preparing regulatory submission.
- Familiarity with GCP required, GMP and GLP preferred
- Strong executive presence and scientific orientation required.
- Must be entrepreneurial, collaborative, and an energetic self-starter with strong interpersonal and analytical skills and the proven ability to work effectively with a CEO and other senior management as a strategic partner.
- Requires the ability to establish and maintain credibility with internal and external scientific and business experts.
- Must be willing to explore new options with regulators.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.