Commercial Regulatory Affairs Director

SUMMARY / JOB PURPOSE :

Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidances and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis’ FDA (Food and Drug Administration) approved products, as well as, materials for scienfitic-exchange communications.

This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view.

This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.

Provides timely and solutions-oriented reviews of assigned advertising and promotion materials with a high level of independence.

Responsible for the regulatory review and approval of advertising and promotional materials and scientific exchange communications.

Serves as decision-making member of the Review of Advertising, Marketing, and Promotions (RAMP) committee and / or Medical Review committee (MRC).

Serves as RAMP Chair overseeing the review and approval of RAMP and / or MRC materials. Able to recognize issues requiring escalation and lead RAMP through escalation process.

Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with a high level of independence.

Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed.

Manages the development of relevant correspondence with health authorities and interpretation of health authority comments.

Responsible for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.

g., external patient recruitment materials). Decision-making member of the Medical and Scientific Exchange Review Committee.

Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters.

Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed.

Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees.

Provides leadership within the Commercial Regulatory Affairs department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.

Responsible for oversight of promotional material submissions under Form FDA 2253.

Maintains current awareness of evolving health authority interpretations, including advisory letters, enforcement letters, policy issues and guidance recommendations.

Conducts benchmarking project for new initiatives and / or activities.

Reviews and evaluates industry environment; performs competitive intelligence on promotional materials and activities.

Manages, maintains, and continuously improves processes and systems (including a web-based platform) for review and approval of promotional materials.

Oversee and manage training on processes and systems.

Leads creation and maintenance of Commercial Regulatory SOPs and work instructions for review, approval, and maintenance of promotional materials.

Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.

SUPERVISORY RESPONSIBILITIES :

None

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Bachelor’s degree in related discipline and a minimum of thirteen years of related experience; or,

Master’s degree in related discipline and a minimum of eleven years of related experience; or,

PhD degree in related discipline and a minimum of eight 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, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results.

Takes pride in delivering high quality work.

Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage 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 cross-functional groups of colleagues.

Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.

Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.

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

Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.

Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.

JOB COMPLEXITY :

Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.

Plans and executes multiple activities.

Considers alternative methods and contingency plans to avoid potential issues.

Designs and implements solutions to address project level challenges, taking into consideration the broader impact.

WORKING CONDITIONS :

10% travel (as needed).

Notice to Recruiters / Staffing Agencies

Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department.

Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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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 $179,500 - $255,500 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.