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Regulatory Program Director, CMC

Company: Gelsi Ltd
Location: Vacaville
Posted on: September 12, 2020

Job Description:

South San Francisco

California, United States of America

We are innovation, curiosity and diversity – multiplied by 80,000 professionals in 150 countries. Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche’s ground-breaking therapies to more than 120 million patients around the world. As one of the global PT functions, the Pharma Technical Regulatory (PTR) Biologics Marketed team builds, maintains, and expands our biological licenses by driving innovative regulatory lifecycle management of products. We are passionate about ensuring reliable supply of quality medicine to our patients.

Change has been a constant in the recent years. Professional know-how, methodological knowledge, consulting competence as well as strong interpersonal skills are important success factors. We strongly believe that you as an employee are at the center of your development and development is about learning – and this can happen everyday. We are also passionate about building strong connections worldwide and are looking for individuals who can join us on our journey.

Job Responsibilities:

We currently have an opportunity for a Regulatory Program Director to join our global PTR Biologics Marketed team. Your key responsibilities will include:

Accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.

Accountable for submissions of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.

Effective management of regulatory changes throughout the product life cycle. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required.

Coordinating and/or leading health authority interactions for assigned projects; representing Technical Regulatory at multidisciplinary meetings with health authorities.

Representation of PTR on other cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs).

Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.

If applicable, leading a Technical Regulatory Team (TRT) of one or several technical regulatory professionals (depending on complexity of the program), which includes the ability to effectively delegate to team members and compile the resource needs for centralized planning.

Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.

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Job Responsibilities/Qualifications:

Must have a Bachelor's degree - preferably in a scientific field; an advanced degree is a plus.

A minimum of 12 years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience.

A regulatory professional with a depth of technical experience and knowledge and the ability to manage complex issues with efficiency.

Experience in CMC regulatory considerations for biologics is preferred; other modalities including small molecules, device/combination products, etc. as well as Marketed Products are an advantage.

You should bring experience in technical (CMC) development, sound knowledge of global regulations and successful management of complex regulatory submissions. Direct interaction with Health Authorities is preferred.

Strong leader who is an agile strategic thinker with exceptional communication skills.

Possesses the ability to work effectively both within a team environment and independently.

You should be able to influence teams and functions in defining global technical regulatory strategies.

You are comfortable with taking risks, experimentation and ambiguity

*Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, will be considered. #LI-DL1

#ptcareers

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 .

South San Francisco

California, United States of America

Company/Division Pharmaceuticals

Schedule Full time

Job type Regular

Additional Locations Oceanside

California, United States of America

Hillsboro

Oregon, United States of America

Vacaville

California, United States of America

Keywords: Gelsi Ltd, Vacaville , Regulatory Program Director, CMC, Other , Vacaville, California

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