AD / Director, Global Regulatory Strategy
Posted on: January 12, 2022
About this role:
As the AD/Director, Global Regulatory Strategy, you will be
responsible for developing and delivering innovative, breakthrough
global regulatory strategies for product development and approval,
in alignment with the global business strategy. You will be
responsible for leading a comprehensive and strategic approach to
developing and executing integrated global regulatory strategies
that account for the complex interplay between major Health
Authorities (including US, EU, JP, and China). You will also
represent the company with domestic and international regulatory
authorities, contractors and corporate partners. Additionally, you
will provide regulatory support for various departments, projects,
What You'll Do
- You are responsible for directing global regulatory strategies
for assigned projects and programs.
- You will have direct global clinical and pre-clinical
regulatory strategies and global life cycle management of
- You will identify and assess regulatory risks associated with
product development and define strategies to mitigate risks.
- You will provide regulatory guidance to company personnel
throughout the research and development process.
- You will set strategic direction and lead the global regulatory
submission process with the submission teams, including marketing
applications and core briefing packages.
- You will develop and maintain the Core Data Sheet and lead
global labeling team meetings.
- You will advise on global CTA submission strategy.
- You will direct the organization and preparation of clear and
- You will Prepare and deliver effective presentations for
external and internal audience.
- You may monitor and analyze appropriate regulatory agency
activities in areas of interest to the company and assess impact on
- You would have the opportunity to mentor Regulatory Managers
and guide direct reports in carrying out responsibilities. You will
also be responsible for coordinating activities and career
development of direct reports.
- You will build and maintain excellent relationships with
relevant regulatory agencies, contractors and corporate partners
while negotiating company position.
- You would be able to provide leadership on project teams and
subcommittees in all areas of regulatory affairs and product
- You will maintain a global view as part of the whole regulatory
B. Additional Functions
- You take steps to actively improve interdepartmental
- You are an active participant in outside relevant conferences,
including organizing and delivering presentations.
- You may have presence on external regulatory committees/trade
Who You Are
In addition to having exceptional relationship building with the
agencies, you successfully worked in a matrix environment where you
collaborated with other teams within the organization. You have
strong Global Regulatory experience along with strong teamwork
- Degree in Life Science or related discipline required. Higher
degree preferred (PharmD, MSc, PhD, MBA).
- 8+ years' experience in the pharmaceutical industry within
R&D, Regulatory or a related function, with at least 5 years
working in regulatory affairs.
- Extensive experience working on products in development
specifically relating to clinical and pre-clinical regulatory
aspects of the project.
- Expert knowledge with respect to the respective regulatory
landscapes in the US, EU, and Japan.
- Direct experience in interfacing with relevant regulatory
authorities (FDA, EMA, and PMDA).
- Experience in interpretation of regulations, guidelines, policy
- Experience and knowledge in the preparation of major regulatory
submissions and supportive amendments or supplements.
- Foster effective, positive interactions with regulatory
agencies, and corporate partners.
- Ability to lead and influence project teams, committees, etc.
to attain group goals.
- Demonstrate excellent leadership and communication skills.
- Ability to represent the department in project teams,
committees and external meetings.
- Demonstrate strong organizational skills, including the ability
to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively
with a variety of senior personnel including medical, scientific,
and manufacturing staff.
- Strong sensitivity for a multicultural/multinational
environment. Experience leading multi-disciplinary teams.
- Supervisory/mentoring experience, including ability to guide,
train, supervise and prioritize workload of direct reports if
All your information will be kept confidential according to EEO
Keywords: Biogen, Cambridge , AD / Director, Global Regulatory Strategy, Executive , Cambridge, Massachusetts
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