Director - Regulatory Affairs Sangart
THIS JOB HAS EXPIRED Description of Duties:
The Director of Regulatory Affairs is a hands-on position responsible for directing the day to day working of the regulatory affairs department including regulatory operations, submissions and communications with health authorities. This person will be responsible for ensuring that the product development plans include consideration of all applicable guidelines and regulations in both US and International, with emphasis on the EU. This individual will provide both a strategic and a directional role on the project teams and must be well-organized, an effective communicator, and capable of performing critical assessments on complex issues of product development.
Develop and implement strategies, in conjunction with the VP of Regulatory Affairs, for earliest possible approvals for Phase 1 through Phase 4 applications
Provide guidance and advice to project teams as the regulatory representative to address issues and challenges for effective communication with health authorities, as well as how to satisfy applicable regulatory requirements.
Serve as a liaison with domestic and international regulatory authorities for assigned projects.
Direct the development and implementation of sound national and international regulatory strategies for multiple products.
Direct timely organization, preparation and submission of scientifically valid submissions according to project timelines that are compliant to health authority requirements.
Direct the regulatory activities associated with product development activities to ensure compliance to health authority law, regulation, and guideline.
Work with other departments to ensure data accuracy and integrity relating to health authority reporting requirements.
Participate in corporate due diligence efforts as directed by VP.
Prepare teams for and present as directed by the VP at Health Authority meetings including EMA and FDA.
Provide final review and sign-off for submissions as directed by VP.
Assure that original INDs, BLAs, MAAs, and major supplements, amendments and variations thereto, are prepared to meet the highest regulatory standards for content and format.
Ensure that Regulatory Affairs is appropriately represented on project teams, and that regulatory support is provided to staff of other departments.
Direct the activities of the regulatory team and consultants
Serve as coach and mentor to departmental members; train regulatory personnel to ensure skills are commensurate with job needs
A minimum of a BS in a scientific field is required (advance degree a plus)
10+ years progressive in regulatory affairs in blood products and/or biotechnology with experience in successful product approvals.
5+ years of direct supervisory experience of regulatory personnel and contractors.
Direct experience in directing the regulatory aspects of a large Phase 2/3 multinational programs; emergency research experience a plus
Direct experience in preparing for licensing activities in US and international, with emphasis on the EU.
Direct experience in directing Regulatory Operations function, including compliant eSubmissions (INDs, CTAs, BLAs, MAAs) and archival responsibilities.
Direct experience with transferring site of manufacture for bulk drug substance and final product
Excellent organizational leadership and communication skills, both written and oral.
Solid knowledge of the regulations applying to biologic and blood products and a proven ability to apply that knowledge to a successful product development.
Track record of success in regulatory authority interactions, specifically, FDA and EMEA.
Proven ability to proactively work cross-functionally on product development teams.
Experience providing strategic direction and management for Blood Products and or Biotechnology derived products in all stages of development including early development through submission and approval.
||6175 Lusk Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED