Reference #: JR5691 SUMMARY/JOB PURPOSE: Manage and perform the operational activities around regulatory submissions to various health authorities in a variety of media (including both paper and electronic media) across clinical and commercial programs. Oversight of regulatory submission planning, scheduling, formatting, publishing, quality control checks, transmitting, archiving, and other operational coordination of regulatory submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Prioritize, plan, and prepare investigational new drug (IND) and new drug application (NDA) submissions to the FDA and ex-US clinical trial applications using various required media (e.g., CDs for Health Canada) and electronic publishing tools

Shared responsibility for establishing the infrastructure to support in-house publishing of certain electronic regulatory submissions in eCTD format.

Independently format, publish, transmit and archive certain submission types; oversee development and maintenance of processes, templates, and style guides to facilitate high-quality published content

Ability to identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing

Manage and collaborate with eCTD publishing vendor, including managing e-publishing software and training staff for certain in-house publishing activities

For complex submissions, track and manage workflow timelines internally and with publishing vendor to ensure corporate milestone goals

Assignment of submissions with appropriate status tracking within the Regulatory Operations department; provide status updates and communications to Regulatory Operations and Regulatory Affairs staff.

Manages daily Health Authority submission schedule in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar.

Facilitate the internal review and approval process for regulatory submissions.

Routinely surveil relevant guidance released by health agencies and present findings/interpretation to team members as needed.

SUPERVISORY RESPONSIBILITIES:

None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:

Bachelor's degree in related discipline and a minimum of nine years of related experience; or,

Master's degree in related discipline and a minimum of seven years of related experience; or,

PhD degree in related discipline and a minimum of two years of related experience; or,

Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.

Applies knowledge of the regulatory framework and industry practices to complete routine 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 small groups of departmental colleagues.

Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.

Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.

Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.

Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

JOB COMPLEXITY:

Capable of following predefined procedures for specific tasks.

Capable of anticipating, identifying, prioritizing and resolving task-related challenges.

Identifies and escalates issues that may have a broader impact.

Imple ents solutions to address any task-related challenges.

WORKING CONDITIONS:

Travel approximately 20%

#LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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 $128,500 - $182,000 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.

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.