Director, Global Regulatory Affairs
Location: San Rafael
Posted on: January 9, 2022
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
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.
SUMMARY DESCRIPTION This role is Global Regulatory Lead responsible
for the management of product in late-stage development and life
cycle management, including development of new indications. The
Global Regulatory Lead will be responsible for developing and
delivering innovative, breakthrough global regulatory strategies
for product development and approval, in alignment with the global
business strategy. Responsible for leading the Global Regulatory
Team (GRT) and developing and executing comprehensive, integrated
global regulatory strategies that account for the complex interplay
between major Health Authorities (including US, EU, JP, and rest of
world). The GRL role is a critical matrixed team leadership role
and is Regulatory voice at the Core team and Corporate Governance
forums representing and accountable for the global regulatory
strategy. Represent the company with domestic and international
regulatory authorities, contractors and corporate partners. Provide
regulatory support for various departments, projects, and
teams/committees. KEY RESPONSIBILITIES:
- Duties Responsible for leading GRT and directing global
regulatory strategies for assigned program and ensuring execution
of these strategies.
- Direct global clinical and pre-clinical regulatory strategies
for development and global life cycle management of products.
- Support development of the late-stage clinical development
- Identify and assess regulatory risks associated with product
development. Define strategies to mitigate risks.
- Set strategic direction and leads global regulatory submission
process with submission teams, including marketing applications and
core briefing packages . Guide the team by creating a shared
understanding of global submission priorities and requirements
understanding any impact on individual and collective regulatory
resources and/or translate into resource needs so that priorities
can be met.
- Oversee and ensure timely execution of HA meetings in line with
the GRP and available guidance's, ensuring reviews of planned
Health Authority interactions, risks, and mitigations ensuring they
are incorporated into the GRP and aligned with core team and
corporate goals. Work with the regional/functional lead for the
creation of global regulatory submissions and plans for heath
authority interactions as defined in the GRP (e.g., CTAs, MAs,
variations/supplements, annual reports, ODD, response to questions,
expedited review requests, etc.) to ensure there is clarity of
roles/responsibilities required to obtain timely deliverables.
- Serve as an advisor/reviewer of content for INTL agency
meetings and submissions (i.e., ODDs, MAs, RTQs), and MA
maintenance (i.e. amendments, renewals, PMCs, safety reporting
- Ensure fulfillment of global clinical and nonclinical
PMRs/PMCs, including timely and effective communication of HA
feedback (post-marketing study expectations and
commitments/milestones) to relevant partner teams and the GRT;
liaise with regional stakeholders on the global PMR fulfillment
status and any relevant HA feedback, as appropriate
- Develop and maintain the Core Global Dossier and collaborate
with lead global labeling team on the company Core Data Sheet.
- Collaborate with project managements to direct the organization
and preparation of clear and effective submissions and
- Prepare and deliver effective presentations for external and
- Provide input to regulatory strategy forums with Regulatory
Senior Management teams and represent Regulatory at governance
- Monitor and analyze appropriate regulatory agency activities in
areas of interest to the company. Assess impact on programs.
- Mentor Regulatory Managers and guide direct reports in carrying
- Responsible for coordinating activities and career development
of direct reports.
- Build and maintain excellent relationships with relevant
regulatory agencies, contractors and corporate partners while
negotiating company position.
- Provide leadership on project teams and subcommittees in all
areas of regulatory affairs and product development.
- Maintain a global view as part of the whole regulatory team.
- Advocate for BioMarin by building strong relationships with
Health Authorities and other external stakeholders as required to
facilitate sound decision-making.
- Take steps to actively improve interdepartmental
- Actively participate in and contribute to outside relevant
conferences, including organizing and delivering
- May have presence on external regulatory committees/trade
associations COMPETENCIES Decision Making and Problem Solving ,
including an ability to coach and mentor teams to develop creative
and novel solutions . Influence, Cross-Functional Collaboration and
Organizational Awareness , including an ability to leverage
organizational knowledge, tact, and connections to stakeholders
across the organization to extract necessary information quickly
and effectively while strengthening inter-departmental
relationships . Agility and Proactivity , such as consistently
expecting, driving for and delivering excellence and optimal
outcomes. Leadership , such as skill in building high functioning,
effective teams that receive positive feedback from stakeholders .
Communication , including an ability to ensure that employees, at
all levels, fully understand their roles in achieving success .
Strategic Thinking and Planning , such as an ability to hold in
mind the vision and purpose of the function, along with broader
company objectives, when making decisions . Regulatory Strategy and
Frameworks : such as an ability to effectively develop and
represent the regulatory position/solution in challenges associated
with lifecycle/commercialization. Scientific Writing for Regulatory
Submissions : Able to conduct comprehensive regulatory submission
document evaluations including evaluation of the quality and
completeness of content . EDUCATION AND EXPERIENCE
- Degree in health or life sciences, significant experience in
Global regulatory affairs including the post-approval management of
product licenses, expanding indications, and of the regulatory
aspects associated submitting and maintaining licenses at a country
level. Knowledge of regulatory frameworks at Global level, and the
ability to apply these to regulatory solutions. Experience in
management/leadership, development and retention of high-quality
regulatory affairs professionals.
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. Be the first to receive
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- The list has BioMarin ranked #4 in America and #1 in the "Drug
& Biotechnology Industry" 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. If
you have a disability and believe you need a reasonable
accommodation in order to search for a job opening or apply for a
position, email Applicant_accommodations@bmrn.com with your
This email address is not for general employment inquiries or
correspondence. We will only respond to those requests that are
related to the accessibility of the online application system due
to a disability.
Keywords: BIOMARIN, San Rafael , Director, Global Regulatory Affairs, Executive , San Rafael, California
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