Associate Regulatory Program Director
Company: GENENTECH
Location: Oceanside
Posted on: January 8, 2021
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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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