Sr. Associate/ Manager Regulatory CMC
Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: November 18, 2021
BioMarin is the world leader in delivering therapeutics that
provide meaningful advances to patients who live with serious and
life-threatening rare genetic diseases. We target diseases that
lack effective therapies and affect relatively small numbers of
patients, many of whom are children. These conditions are often
inherited, difficult to diagnose, progressively debilitating and
have few, if any, treatment options. BioMarin will continue to
focus on advancing therapies that are the first or best of their
kind. BioMarin's Research & Development group is responsible for
everything from research and discovery to post-market clinical
development. Research & Development involves all bench and clinical
research and the associated groups that support those endeavors.
Our teams work on developing first-in-class and best-in-class
therapeutics that provide meaningful advances to patients who live
with rare diseases. Come join our team and make a meaningful impact
on patients' lives. RESPONSIBILITIES
- Oversee the planning, preparation and submission of global
regulatory CMC-related content pertaining to clinical trial
applications, marketing Application(s) and periodic reports for US
and Ex-US markets in accordance with the developed regulatory
strategy. Ensure that the sections are complete, well-written, and
meet all relevant requirements.
- Collaborating with Reg CMC Product Lead to assess change
records of proposed manufacturing changes and provide strategic
regulatory guidance for optimal implementation of changes.
- Developing and/or reviewing regulatory documents to ensure that
all submissions are complete, accurate and meet relevant
- Manage the timelines and deliverables to ensure submissions are
aligned with program milestones.
- Proactively identify issues and suggest appropriate strategies
to mitigate risks.
- Develop relationships with internal functional groups, contract
manufacturing organizations, and partners.
- Provide regulatory advice to technical operations departments
based on knowledge of current requirements.
- Process documentation requests to support key application
- Manage interactions with FDA or other regulatory authorities
for assigned projects. EDUCATION
- BA/BS degree in life sciences in chemistry, molecular biology,
or similar is desirable. Advanced degree is a plus. EXPERIENCE
- At least 3 years of experience in Regulatory Affairs or a
related discipline in the pharmaceutical or biotechnology industry
(preferably with exposure to both development and commercial phases
of product lifecycle)
- Experience in filing post-marketing supplements, INDs, CTAs for
pharmaceutical or biologic products in the US and/or Europe is
- Thorough understanding of relevant drug development regulations
and guidelinesOutstanding interpersonal and communication (written
and verbal) skills; proficient with computer and standard software
programs. We are an equal opportunity employer and all qualified
applicants will receive consideration for employment without regard
to race, color, religion, gender, gender identity, sexual
orientation, national origin, disability status, protected veteran
status, or any other characteristic protected by law.
Keywords: BioMarin Pharmaceutical Inc., San Rafael , Sr. Associate/ Manager Regulatory CMC, Executive , San Rafael, California
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