Director, Regulatory Affairs
Company: ICON Clinical Research
Location: Denver
Posted on: May 27, 2023
|
|
Job Description:
Director, Regulatory Affairs
Location: Any location in the US. Remote or Office based.
Due to a number of exciting new projects being awarded to ICON, we
are seeking to expand our team and expertise, with the recruitment
of a Director of Regulatory Affairs within our US team. We are
looking for passionate, resilient, and inspiring individuals to
join our Strategic Regulatory Affairs (SRS ) team. SRS are a global
team of regulatory strategists from pharma, CRO and agency
backgrounds, with expertise in drug development, regulatory
strategy and operational implementation. We deliver global
strategic regulatory consulting, dossier management services and
GMP Quality services
As a Director, Regulatory Affairs, you will create a culture of,
process improvement with a focus on streamlining our processes,
adding value to our business and meeting client needs. Representing
ICON as a Subject Matter Expert for Regulatory Affairs in the US
market you will proactively communicate objectives and results with
clients offering strategic regulatory advice.
In this role, you will be responsible for regulatory strategy for a
combination of current and prospective clients in the US for drugs
and biologics. As a senior member of the SRS team, you will further
be responsible for the strategic approach and client interactions
necessary to securing new and repeat business, facilitating issue
resolution and ensuring project/program timelines/budgets are met.
You will also maintain client relationships in the support of
future business as the position participates in business
development activities.
Responsibilities and accountabilities:
Actively anticipate, develop and implement initial or alternative
regulatory strategies for contracted clients.
Act as scientific thought leader for ICON. Support initiatives to
ensure ICON is at the leading edge of new regulatory developments
e.g. COVID-19, GMO, ATMP development, Cell and Gene therapy
etc.
Provide clients with strategic advice in response to their queries,
based on regulatory experience and area of expertise, consulting
with other resources within the organization as required.
Manage workflow including prioritizing project objectives, and
establishing timeframes for projects with clients and managing
client contracts.
Effectively prioritize and complete multiple projects within
established timeframes and within budget
Train, coach, and develop assigned individuals to build overall
team expertise
Function as primary liaison with FDA for designated projects and
designated clients
Conceptualize and draft complete proposals based on a client idea
or (Request for Proposal (RFP) including Independent development of
project plans and scientific content for clients. Achieve a good
conversion rate of submitted to won proposals.
Act as scientific thought partner with the client and the project
team throughout the project.
May lead a team
Knowledge/Skills/Attributes
Leading FDA pre -IND, End of Phase 2 and Pre NDA/BLA meetings with
FDA.
Experience with small molecules, biologics, gene therapy and cell
therapies.
Post market support experience
Excellent verbal and written communication: Conveys thoughts in a
clear, concise, and accurate manner. Uses appropriate regulatory,
medical, and scientific nomenclature. Listens carefully and asks
questions when necessary to ensure understanding
Planning and organization: Plans work effectively to meet goals and
ensure timely completion of assignments. Manages time
effectively.
Attention to detail: Identifies and resolves discrepancies across
various source documents, including published and unpublished
documents. Notes and resolves errors in written documentation
Experience in client interaction and/or in a consulting environment
is advantageous
Experience in regulatory writing, meeting packages, dossiers
Education/ Experience:
Bachelor's degree in a relevant discipline, preferably in life
sciences, or other healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological,
medical, chemical or engineering field may be beneficial.
Minimum of 12-15 years related experience in Regulatory Affairs
setting, in Pharma or CRO, with emphasis on US Regulatory
Affairs
Experience supporting client development activities and people
management.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've
made it a priority to build a culture that rewards high performance
and nurtures talent.
We offer very competitive salary packages. And to keep them
competitive, we regularly benchmark them against our competitors.
Our annual bonuses reflect delivery of performance goals - both
ours and yours.
We also provide a range of health-related benefits to employees and
their families and offer competitive retirement plans - and related
benefits such as life assurance - so you can save and plan with
confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits,
you'll benefit from an environment where you are encouraged to
fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is
committed to providing a workplace free of discrimination and
harassment. All qualified applicants will receive equal
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the application process,
or in order to perform the essential functions of a position,
please let us know through the form below.
#LI-JC1
#LI-Remote
Keywords: ICON Clinical Research, Denver , Director, Regulatory Affairs, Executive , Denver, Colorado
Click
here to apply!
|