Sr. Director, Regulatory Affairs

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Job description

Our client, a biopharmaceutical company, is looking for a Director/Sr Director, Regulatory Affairs to provide a critical leadership role in the planning and execution of the Company's regulatory strategies and compliance requirements. This position will report to the Head of Regulatory and will work in a highly collaborative environment with team members in Clinical Development, Clinical Operations, CMC, Biostatistics, Nonclinical, Clinical Pharmacology, Program Management, and Research.

This role is full-time, 100% remote.

Specific Responsibilities:

• Plan content and timelines of regulatory submissions to ensure alignment with agreed strategies.
• Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality.
• Lead efforts for coordinating content and publishing documents for INDs, BLAs, and their associated maintenance.
• Work with department management on plans for IND/BLA submissions and lead their preparation.
• Take the lead role in preparation for project documents for Regulatory Agency meetings.
• Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for
• Regulatory Authority meetings.
• Work with ex-US regulatory organizations to prepare applications, respond to queries, and maintain clinical activities outside of the United States.
• Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues.
• Assure compliance with regulatory standards and guidance documents.
• Prepare, submit, track, index, and archive electronic submissions.
• Provide Regulatory guidance to Development and Research teams.
• Liaise with external CRO Medical Writing and Regulatory Operations functions for coordinating and publishing submission documents.
• Other tasks and responsibilities as directed by the SVP, Global Regulatory Affairs and Quality Assurance.

Key Qualifications:

• B.S./M.S. degree in a relevant discipline.
• Minimum of 8 years of Pharmaceutical Regulatory Affairs experience.
• Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required.
• Experience supporting development stage programs (Phase 1-3); Experience in neurodegenerative disease research highly desirable.
• Strong analytical skills, problem solving ability, and presentation skills.
• Familiarity with eCTD technical requirements.
• Highly organized with proficiency accessing documentation utilizing multiple electronic systems.
• Excellent communication and interpersonal skills are essential.
• Residence in the bay area preferred.
• The successful candidate will be required to be fully vaccinated against the Covid-19 virus. You are considered fully vaccinated two weeks after the second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson's Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.

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