Clinical Regulatory Affairs Director

This Bay Area pharmaceutical company is developing and commercializing innovative therapies for women’s health and prostate cancer.  With the anticipated FDA approval of two NDAs this year, they are growing rapidly and expanding their team.  They are seeking a Clinical Regulatory Affairs Director who can develop and lead global regulatory strategies for assigned programs. You will manage health authority interactions and global submissions for various product candidates. This company offers an incredible company culture, competitive compensation, equity, and great employee benefits.  Now is an exciting time to join this rapidly growing organization and help get new products approved!

Key Responsibilities

  • Develop regulatory strategic plans in conjunction with project teams and assist in the design of nonclinical and clinical study programs required for regulatory approval.
  • Set strategy for submissions of product registration documents to health authorities worldwide and oversee filing of IND/CTA/NDA/MAA submissions;
  • Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
  • Provide interpretation of regulatory authorities’ feedback, policies and guidelines to company personnel and serve as a liaison with regulatory authorities.
  • Represent the company before regulatory authorities on designated programs.
  • Work with project teams to resolve complex project issues.
  • Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
  • Effectively plan, organize, and conduct in close collaboration with leads from other functional areas formal meetings with regulatory agencies.
  • Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Assure compliance with project team timelines and milestones.

 

Qualifications

  • Bachelor’s degree in a scientific discipline required. Advanced degree (MS, PhD, PharmD) preferred.
  • 12 years of biopharmaceutical experience, with at least 10 years of direct experience in Regulatory Affairs for prescription pharmaceuticals.
  • A successful track record of developing and executing regulatory strategies for INDs/CTAs, BLAs, MAAS and/or NDAs.
  • Experience successfully filing IND and NDA/MAA submissions.
  • Strong knowledge of US and global regulations and guidances.
  • Experience working directly with FDA and/or other health authorities.
  • Direct experience working on products in development under GCP and GLP settings.
  • Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
  • Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

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