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Associate Regulatory Program Director

Location: Oceanside
Posted on: January 8, 2021

Job Description:

The Position Who we are 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 Development group takes new products from the early stages of development up to product approval. We are passionate about bringing therapies to patients in an agile manner and ensuring supply of quality medicine to our patients. In this position within the PTR department, you will take on the role of a Technical Regulatory Leader or Team member with accountability and/or responsibility for the development and execution of Chemistry, Manufacturing and Controls (CMC) regulatory strategies for biologics products and represent PTR on cross-functional teams. The focus is on enabling global CMC development, dossier preparation and regulatory risk mitigation, leading to successful clinical trial applications and global commercial registrations. Job Description * Accountable and/or responsible for submission of high-quality CMC documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and health authority requirements.* Accountable and/or responsible for development, communication and execution of sound regulatory strategies that meet both global regulatory requirements and enable business objectives. This includes identification and communication of regulatory risks and development of mitigation strategies in concert with technical functions.* Effective management of regulatory changes through the product lifecycle. 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.* Serve as a point of contact with knowledge of the CMC regulatory requirements and represent PTR on cross-functional teams. Driving and making clear decisions in the project team environment.* Responsible for project planning, scheduling, resourcing and communicating of project updates to management and stakeholders.Qualifications * Bachelor's Degree in life sciences and/or engineering. Post Graduate Degree is a plus.* 5 or more years work experience in the pharmaceutical, biotechnology or related industry as appropriate and CMC, quality, regulatory or related experience.* Knowledge of and/or ability to interpret of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO).* Experience as a contributor for regulatory filings or inspections is a plus.* Experience participating in product development and/or other cross functional teams.* Possesses the ability to work effectively both within a team environment andindependently. * Critical thinking, creative problem solving, adaptability and strong communication are essential skills for this position.* Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, may be considered on a case-by-case basis.Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. The next step is yours. To apply today, click on the "Apply for this job" 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 . Job Facts JOB FUNCTION General Regulatory Affairs COMPANY/DIVISION Pharmaceuticals SCHEDULE Full time JOB TYPE Regular

Keywords: GENENTECH, Oceanside , Associate Regulatory Program Director, Executive , Oceanside, California

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