Associate Regulatory Operations Director (Dossier Planner)

Exelixis; Alameda (CA); On-site; USD 158,000 - 223,000; Full time

Benefits offered by this job

401k

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase plan

Long-term incentives

Vacation days

Paid holidays

Sick days

Job summary

Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs and cross-functional teams to achieve filing objectives.

The candidate will guide Veeva RIM practices, develop best practices for submission timelines, mentor staff, interpret guidelines, and drive process improvements to enhance

Qualifications

• Bachelor's degree in related discipline with 11+ years of experience or
• Master's degree with 9+ years of experience; PhD with 5+ years
• Equivalent combination of education and experience.

Responsibilities

• Oversee planning of all regulatory submissions (INDs, NDAs, BLAs) in electronic format.
• Oversee regulatory submission processes, timelines, and deliverables.
• Collaborate with Regulatory Affairs and cross-functional teams to maintain global submission project plans.
• Lead cross-functional team to explore submission process optimization.
• Develop submission planning best practices and major timeline implementations.
• Mentor Regulatory Operations staff on submission planning best practices.
• Review and interpret regulatory guidelines.

Skills

Regulatory submissions planning

Cross-functional collaboration

Strategic planning

Communication

Leadership

Project management

Veeva RIM

Education

Bachelor's degree in related discipline

Master's degree in related discipline

PhD in related discipline

Equivalent combination of education and experience

Tools

Veeva RIM

Project planning tools

Job description

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.

• Leads 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 working.

• 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:

Education/Experience:

• 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.

Experience/The Ideal for Successful Entry into Job:

Knowledge/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 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%

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.

#LI-MB1

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $157,500 - $222,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.