Associate Director/Director, Regulatory Affairs
Our client is a biotech company focusing on drug discovery and drug development. They have asked us to assist them in their search for an Associate Director/Director, Regulatory Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops substance, design, and accountability for regulatory submissions and related supplements and amendments.
- Advises teams regarding regulatory strategy throughout the clinical development processes.
- Assesses new government/regulatory developments and identifies potential areas of regulatory concern.
- Establishes and maintains excellent relationships with regulatory agency personnel.
- Responds to requests for additional data and organizes and manages participation in meetings.
- Negotiates directly with regulatory authorities regarding the company's filings.
- Works on the development and submission of BLA/MAAs.
- Develops, employs, and assesses current policies and practices in compliance with federal and international regulatory agencies.
- Coordinates with other departments and external partners to achieve project goals.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Partners with internal teams and company partners to develop content and manage submissions to regulatory agencies.
- Serves as overall global regulatory lead, accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.
- Represents Regulatory Affairs on cross-functional project teams.
- Effectively communicates the regulatory strategy, risks, mitigations, and overall plans to the Regulatory Affairs management team, Project Development team and senior management, as relevant.
- Ensures the global regulatory strategy is consistent with the business objectives and have been discussed with relevant health authorities.
- May be responsible for line management and development of direct reports in the future.
- BA/BS degree in a scientific/engineering discipline is required, masters or PhD preferred.
- Requires 10+ years of experience in the pharmaceutical industry.
- Must have experience in regulatory strategy, focusing on infectious disease.
- Strong knowledge of current US and EU regulations, including specifically, vaccine development regulations and registration pathways is required.
- Requires strong experience with CTD format and content regulatory filings.
- Must have exceptional written and oral communication.
- Experience with developing and implementing competitive regulatory strategies is required.
- Demonstrated track record in securing product approvals and maintaining a complex portfolio is required.
- Requires experience dealing with broad range of stakeholders at all levels internal and external to the company.
- Must have comprehensive experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance, preferably from both US and EU.
- Direct experience of leading regulatory authority meetings in different phases of drug development is required.
- Requires delivery of at least one major application.
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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