Associate Regulatory Operations Director (Dossier Planner)

Exelixis Inc; Alameda (CA); On-site; USD 157,500 - 222,500; Full time

Benefits offered by this job

401(k) plan

Group medical, dental, and vision coverage

Discretionary annual bonus

15 accrued vacation days in the first year

17 paid holidays

Up to 10 sick days

Job summary

Exelixis Inc in Alameda, California, is looking for an Associate Regulatory Operations Director to oversee regulatory submission activities and ensure effective collaboration within cross-functional teams. This position requires extensive knowledge of global regulatory requirements and involves managing submission processes and developing best practices.

The role offers a competitive compensation package between $157,500 to $222,500, comprehensive benefits like a 401(k) plan, medical coverage, and ample vacation days.

Qualifications

• Minimum of 5 years experience with a PhD, 9 years with a Master's, or 11 years with a Bachelor's.
• Proven ability to manage complex tasks and projects.
• Strong problem-solving skills with a focus on quality work.

Responsibilities

• Oversee regulatory submission planning and processes.
• Collaborate with teams to maintain project plans and timelines.
• Identify IT solutions to enhance Regulatory Operations systems.

Skills

Regulatory framework knowledge

Communication skills

Interpersonal skills

Problem-solving

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

PhD degree in related discipline

Tools

Veeva RIM

Project planning tools

Job description

Overview

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, driving 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 identifies best practices for effective implementation.

Responsibilities

• Oversee 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.
• Work collaboratively with Regulatory Affairs and contributing cross‑functional team members to create and maintain global regulatory submission project plans, manage deliverable timelines, ensure alignment on roles and responsibilities, and assess any issues, risks or impacts due to changes in strategy and/or timelines quickly throughout the submission process, ensuring transparency of submission status to key stakeholders and management.
• Lead a cross‑functional team within Exelixis to explore submission process optimization.
• Develop submission planning best practices and implement major submission timelines.
• Partner with the Vice President, Regulatory Operations in the development and implementation of Department best practices and ways of working.
• Provide key insight to identify IT solutions to enhance Regulatory Operations systems (e.g., Project planning tools, Veeva RIM).
• Participate in the writing of regulatory processes (SOPs, work instructions, and/or internal guidelines) and other departmental initiatives to improve standards and systems internally.
• Mentor/instruct members of the Regulatory Operations team on Best Practices for submission planning.
• Review and interpret regulatory guidelines.

Education and Experience

Minimum qualifications:

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

Qualifications and Skills

• 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.

Job Details

Job Complexity: Capable of managing the execution of multiple tasks. Ensures appropriate prioritization and execution for area of responsibility. Proactively anticipates, prioritizes and resolves task‑related challenges. Designs and implements solutions to address task‑related challenges, taking into consideration the broader impact.

Working Conditions: Travel approximately 20%.

Compensation and Benefits

The base pay range for this position is $157,500 - $222,500 annually. The base pay may vary based on geographic region, job‑related knowledge, skills, experience and internal equity. Exelixis offers a comprehensive benefits package including a 401(k) plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, optional stock purchase, long‑term incentives, 15 accrued vacation days in the first year, 17 paid holidays and up to 10 sick days. Employees may also be eligible for a sales‑based incentive plan if field sales staff.

Equal Opportunity Employment

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.