Senior Manager, Regulatory Affairs
Posted on: July 14, 2019
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical
and a leader in a new industry model - Growth Pharma. Allergan is
on developing, manufacturing and commercializing branded
device, biologic, surgical and regenerative medicine products for
around the world.
Allergan markets a portfolio of leading brands and
products for the central nervous system, eye care, medical
dermatology, gastroenterology, women's health, urology and
anti-infective therapeutic categories. With commercial operations
approximately 100 countries, Allergan is committed to working with
healthcare providers and patients to deliver innovative and
treatments that help people around the world live longer, healthier
is a company that will inspire you to aim high with your ambition.
can build bridges all over the world. Where you can power ideas
change. And where you will act fast and drive results for customers
patients. Power your future & join our bold team.
Plans and prepares complex medical device regulatory
submission documents for US, Canada, and international regulatory
Utilizing detailed, in-depth understanding of medical device
and participates in global regulatory teams, interprets
provides regulatory guidance.
Main Areas of Responsibilities
- Submissions, development and lifecycle
- Plans and prepares complex
regulatory documents for US and international product approvals
- Resolves submission problem
areas with team or direct supervisor.
- Prepares clear and accurate
internal and external complex administrative and scientific
under minimal supervision.
- Prepares complex expository and
technical documents, logically constructed and comprehensive in
- Prepares documentation that is
complete, accurate, and on time.
- Manages post-approval projects
not requiring a global core team. Plans and implements
activities that support lifecycle management (e.g. Clinical
Report support, annual reports, changes, etc.)
- Reviews labeling and packaging
components to ensure accuracy and compliance with government
Submits product labeling in compliance with legal/regulatory
and communicates planned/approved changes with operations,
medical affairs and marketing.
in global teams and provides regulatory strategy and guidance to
product development teams.
minimal supervision, develops US regulatory filing strategy. Works
international colleagues to develop filing strategies outside the
reviews complex reports, validations, etc. for scientific merit
regulatory appropriateness. Works collaboratively with
team to resolve project issues.
recognized regulatory expertise and knowledge of regulatory
with ability to strategically interpret and communicate
planned device development activities comply with US and global
guidelines, and, in cases where they do not, provides a critical
of the risks and issues with minimal supervision.
- Ensures that teams and
functional groups are provided with clear, constructive regulatory
and intelligence to assist planning and issue resolution during
development and registration
3. Communications and Business
department on global project teams.
relationships with US colleagues as well as global regulatory team
ensure local RA activities are in line with global business
professional relationships with Health Authorities, when
as appropriate with outside vendors, suppliers, contract
organizations, and others.
information on team timelines and status to supervisor.
presentations within the Company, as required.
- Class III medical device
- Experience with implantable
medical devices preferred.
thinking and problem solving skills
written and verbal communication skills.
to work well independently and with others.
organizational skills and attention to detail.
to handle multiple projects simultaneously and maintain
with Adobe Acrobat, Excel, Power Point, and Word, and ability to
to understand and use technical documents, such as regulations
guidance documents, as well as technical reports, in support of
thinking skills and ability to follow-through.
knowledge of US medical device regulations as well as
knowledge of Canadian and EU regulations.
to demonstrate leadership in job performance by example.
to function in a regulated environment and handle confidential
to lead and motivate others.
to meet deadlines; take initiative and make decisions within
- Education equivalent to a BS
degree in a scientific field, plus 8 years' experience in
- Education equivalent to a MS
degree in a scientific field, plus 6 years' experience in
- Education equivalent to a PhD
degree in a scientific field, plus 4 years' experience in
Keywords: Allergan, Irvine , Senior Manager, Regulatory Affairs, Executive , Irvine, California
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