22 días de edad

Sr. Director, Regulatory Affairs

Revance Therapeutics Inc.
Newark, CA 94560
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  • código de trabajo
    132437660
Category: Clinical & Regulatory Affairs
Location: Newark, California

Description

Position Summary

This position leads the execution, maintenance and monitoring of Regulatory submissions in compliance with approved procedures, with a focus on clinical development. This position recommends regulatory strategy for development of clinical trials that meet desired commercial labeling claims and supports review and approval of all labeling and promotional materials. This position manages resources necessary for global regulatory submissions of development programs, including original clinical trial submissions, biologic license applications and supplemental biologic license applications.

Essential Duties/Responsibilities
  • Develops, recommends and implements strategies for earliest possible approvals of phase 1 through phase 4 applications.
  • Leads and manages draft/review/compiling of IND/CTA, BLA/MAA, and other global submission documents.
  • Ensures that timely, risk-balanced guidance, with contingencies, is provided to project teams and senior management to assure that regulatory requirements are incorporated into development process.
  • Develops positive and proactive approaches to regulatory compliance to ensure client satisfaction, providing counsel to and managing the regulatory team.
  • Leads and manages regulatory functions and projects by working with other members of the management team and cross-functional development team.
  • Develops overall timelines and plans by working with team members in research and development, QA, Operations and Clinical Affairs to ensure regulatory requirements are properly covered and implemented as part of product development plans.
  • Interacts with regulatory agencies on defined matters.
  • Reviews and approves publicly disseminated information to minimize regulatory exposure; review product claims; and preserve confidentiality of applicable product information.
  • Mentors, guides and trains direct reports and cross-functional team members to increase regulatory affairs awareness.
  • Oversees and manages regulatory documentation infrastructure, including e-submissions.
  • May lead training of functional areas and assist in the development of training sessions.
  • May develop and manage Regulatory Affairs department budget and monitor expenditures.


Education
  • BA/BS or Master's Degree (or higher) in a scientific discipline or equivalent combination of education and experience is required.


Experience
  • Minimum 10 years of experience in the pharmaceutical, device or diagnostic industry with at least 7 of those years in Regulatory Affairs for drug or biologic products, with expertise in clinical regulatory strategy, labeling and advertising/promotion. Experience with biosimilar programs is desired.


Knowledge, Skills and Abilities
  • Extensive experience and knowledge of drug/medical device/biologics regulations to ensure that Regulatory adheres to requirements, company procedures, and is consistent with industry standards.
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Working knowledge of electronic publishing systems and CTD format.






PI132437660

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Posted: 2021-03-22 Expires: 2021-04-22

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Sr. Director, Regulatory Affairs

Revance Therapeutics Inc.
Newark, CA 94560

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