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.

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 :

May supervise 1 or 2 employees.

Train and mentor employees to promote professional growth.

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Bachelor’s degree in related discipline and a minimum of eleven (11) years of related experience; or,

Master’s degree in related discipline and a minimum of nine (9) years of related experience; or,

PhD degree in related discipline and a minimum of five (5) years of related experience; or,

Equivalent combination of education and experience.

Experience / The Ideal for Successful Entry into Job :

Proven leader with a minimum of 10 years within Regulatory in the pharmaceutical / biotech industry.

Demonstrated organizational / planning skills with submissions / project management experience.

Knowledge / Skills :

Deep knowledge and understanding of the drug development process and regulatory requirements

Experience in the full range of regulatory submissions from IND to NDA and ex-US equivalents

Highly knowledgeable in the CTD / eCTD structure and requirements and a solid understanding of submission requirements for submission types (e.

g., IND, CTA, NDA, MAA, BLA, etc.)

Strong knowledge of Microsoft Office suite, Microsoft Project and / or other project management tools, Adobe acrobat, ISI toolbox, Electronic Document Management Systems (e.

g., Veeva, Documentum, FirstDocs, etc.), eCTD publishing tools (e.g., eCTDXpress), eCTD validation and viewing tools

Ability to lead complex projects and timelines in a matrix team environment

Demonstrated leadership ability, with strong negotiating and influencing skills

Mentor staff in creating high quality submission plans for major / complex submission filings

JOB COMPLEXITY : WORKING CONDITIONS :

WORKING CONDITIONS :

Environment : primarily working indoors

Travel required 20%

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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.

The base pay range for this position is $146,000 - $206,500 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.

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.