Associate Group Director, CMC Regulatory, Bio Marketed Products

South San Francisco, California
United States

Job ID: 3089305607

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The Position

Location:  Position can be located in South San Francisco, CA, Vacaville, CA, Oceanside, CA or Hillsboro, OR

 

Who We Are:

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

 

GENERAL POSITION SUMMARY

In this position, the Group Leader is also responsible for the management of four or more regulatory professionals, which includes setting performance objectives, providing timely feedback, and ensures alignment of short-term development goals with longer-term career goals. Provides guidance and manages work activities of others for specific projects and/or objectives. Demonstrate the fundamentals of effective coaching skills and mentoring. Adapts coaching style to meet the needs of the individual.

The Group Leader leads cross-functional regulatory initiatives and strategies, defines associated critical steps and resources needed for them and takes responsibility for implementation of these initiatives and strategies. Proactively communicate with regulatory and cross-functional personnel in support of internal and partner-associated project goals. Collaborate with management in leading communications with HA on projects and initiatives of major complexity. Makes decisions based on cross-functional priorities rather than functional area priorities.

JOB DESCIPTION – primary duties and responsibilities

• Provide regulatory leadership and oversight to a team of regulatory professionals.

• Responsible for coaching and mentoring team members and be responsible for guiding and overseeing implementation of regulatory strategy and making decisions that ensure the high quality of regulatory submissions for commercial products in our portfolio in alignment with the global product management strategies.

• Work with team members and ensure that objective and timely feedback is provided to employees, focus on the development of the employee by facilitating regular development discussions.

• Serve as the voice of the organization and assure that challenges, opportunities and initiatives / actions taken by the leadership teams are communicated to the employees in a meaningful, systematic and thoughtful manner.

• Work collaboratively at the global level, with other group leaders to align on priorities and support the achievement of the team and organizational goals, by reallocating resources to support the projects and initiatives on an as needed basis.

• Serve as the delegate of the global head and adequately represent the department needs and positions senior leadership forums.

• Drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations.

• Develop, execute and provide oversight over regulatory initiatives; strategies of significant complexity and apply ingenuity to solve problems and mitigate potential regulatory challenges.

• Provide regulatory oversight for impact to change control, discrepancy management and inspection management systems. Participate in Quality Review Boards, Change Review Boards and any other relevant governance committees.

 

 

Who You Are

QUALIFICATIONS

Education

 

• Bachelor’s Degree in life sciences disciplines is strongly preferred. Graduate or Post-Graduate Degree in above or related disciplines is a plus.

Experience

• 10 or more years work experience in the pharmaceutical, biotechnology or related industry and 6 or more years’ CMC, quality, regulatory or related experience.

• Experience as a Tech Regulatory Leader (TRL) for a development/marketed product program or equivalent experience is required.

• Previous People management or cross-functional team leadership experience is desired.

 

Knowledge/Skills/Competencies

• Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies.

Regulatory, Strategy and Operational Knowledge

• Understanding of relevant global Health Authority guidelines, and regulatory strategy development.

• Proven knowledge of regulatory dossier requirements and health authority interactions.

• Understanding of technical (quality) regulatory interfaces with stakeholders such as Technical Functions, Quality, Operations, Program Management, Supply Chain and Development.

• Technical understanding of drug product manufacturing, biotechnology and product development processes.

Collaboration and Leadership

• Able to build productive relationships within or across departments as well as partnerships between companies and cultures.

• Outstanding organizational and time management skills; proven ability to work under pressure.

• Exceptional influencing and negotiation skills: extracts optimized business results through skillful collaboration with others (at all levels and across organizations) without formal authority and is highly adept at identifying solutions that will meet the needs of all parties involved.

• Interpersonal and collaboration skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders.

• Team building skills, especially ability to work in a matrixed team environment.

• Demonstrates, or has proven abilities to demonstrate Roche Values and Leadership Competencies.

Communication

• Strong communication and presentation skills: exhibits professional maturity, confidence and competence.

• Able to think on ones feet in front of senior management, high level internal and external stakeholders and to quickly summarize complex issues and conclusions so as to expedite agreements and decision-making.

• Fluent in English, if applicable additional language spoken in the region of responsibility.

 

TRAVEL REQUIREMENTS

Ability to travel up to 20%

 

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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