Associate Regulatory Operations Director

SUMMARY/JOB PURPOSE

The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company’s submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions. She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting submission timelines, drive process efficiencies and overall operational effectiveness for timely and high-quality regulatory submissions. This role also provides oversight and guidance on the Veeva RIM suite and identify best practices for effective implementation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversees the planning of all regulatory submissions (INDs, NDAs, BLAs, supplemental applications, etc.) in electronic format.
• Accountable for the oversight of regulatory submission processes and best practices, bringing clarity to submission timelines and deliverables.
• Works collaboratively with Regulatory Affairs and contributing cross-functional team members in order to create and maintain global regulatory submission project plans, manages deliverable timelines and activities, ensures alignment on roles and responsibilities, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.
• Led a cross-functional team within Exelixis to explore submission process optimization.
• Develops submission planning best practices and implementation of major submission timelines.
• PARTNERS WITH VICE PRESIDENT, REGULATORY OPERATIONS IN THE DEVELOPMENT AND IMPLEMENTATION OF DEPARTMENT BEST PRACTICES AND WAYS OF WORK.
• Provides key insight to identify IT solutions to enhance Regulatory Operations systems (i.e., Project planning tools, Veeva RIM).
• Participates in the writing of regulatory processes (SOPs, work instructions, and/or internal guidelines) and other departmental initiatives to improve standards and systems internally.
• Mentors/instructs members of the Regulatory Operations team on Best Practices for submission planning.
• Reviews and interprets regulatory guidelines.

  SUPERVISORY RESPONSIBILITIES

  None.

  EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

  • Bachelor’s degree in related discipline and a minimum of eleven years of related experience; or,
  • Master’s degree in related discipline and a minimum of nine years of related experience; or,
  • PhD degree in related discipline and a minimum of five years of related experience; or,
  • Equivalent combination of education and experience.

  Knowledge/Skills:

• Experience/The Ideal for Successful Entry into Job: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
• Takes pride in delivering high quality work.
• Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
• Demonstrates clear and effective verbal and written communication.
• Provides timely and appropriate information updates.
• Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
• Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
• Manages effectively performing teams to achieve common objectives.
• Engages internal stakeholders to establish productive collaborative relationships.
• Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
• Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.