Senior Regulatory Operations Manager at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Position Description:

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.

Position Requirements:

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
• 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 projects with appropriate status tracking within the Regulatory Operations department; provide status updates and communications to Regulatory Operations and Regulatory Affairs staff.
• Manage portfolio timelines 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 guidances released by health agencies and present findings/interpretation to team members as needed.

SUPERVISORY RESPONSIBILITIES:
• No direct reports
• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.
• Train and mentor employees to promote professional growth and development of high-quality published content

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
• BS/BA degree in related discipline and eight years of related experience; or,
• MS/MA degree in related discipline and six years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• Typically requires a minimum of six years of related experience and/or combination of experience and education/training.
• At least 3 years of direct experience with regulatory submissions
• Relevant working experience with the FDA (in particular, the Center for Drug Evaluation and Research (CDER)). Equivalent experience with similar regulatory authorities (e.g., European Medicines Agency (EMA) or Health Canada) also desired.

Knowledge/Skills:
• In-depth Regulatory submissions knowledge and familiarity with industry trends, experience with regulatory publishing tools and software with particular expertise in eCTD.
• Experience with eCTD publishing software and with electronic data management systems (e.g., LiveLink) required.
• Superior organization skills are mandatory.
• Proficient knowledge of ICH Common Technical Document (CTD) specifications and other regulations and guidances associated with submissions.
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has high level knowledge of other related disciplines.
• Applies strong analytical and business communication skills.

WORKING CONDITIONS:
• Environment: primarily working indoors, performing clerical work

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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.