Career Opportunities: Director Combination Products Regulatory
Affairs (17602) Requisition ID 17602
- Posted 04/28/2020 - Regulatory
Affairs - US Exton
Director Combination Products Regulatory Affairs
West Pharmaceutical Services, Inc. is a leading manufacturer of
packaging components and delivery systems for injectable drugs and
healthcare products. Working by the side of its customers from
concept to patient, West creates products that promote the
efficiency, reliability and safety of the world's pharmaceutical
drug supply. West is headquartered in Exton, Pennsylvania, and
supports its customers from locations in North and South America,
Europe, Asia and Australia. West's 2018 sales of $1.7 billion
reflect the daily use of approximately 112 million of its
components and devices, which are designed to improve the delivery
of healthcare to patients around the world.
POSITION SUMMARY: This position can be based out of Exton, PA or
Scottsdale, AZ. The Director of Regulatory Affairs is responsible
for developing and implementing Chemistry, Manufacturing, Control
(CMC) regulatory strategies which lead to and maintain regulatory
approvals and compliance for combination products utilizing West’s
innovative medical device in accordance with global regulations and
guidelines. Specific responsibilities include providing CMC
regulatory guidance for clinical phases through commercialization
of combination products, support regulatory submissions, agency
interactions and provide study oversite for Human Factor for
product development and labeling. This role provides leadership and
partners closely with internal and external marketing, R&D,
quality, regulatory and engineering and manufacturing,
PRIMARY DUTIES AND RESPONSIBILITIES:
Serve as the global leader for the development, communication,
lifecycle management of CMC regulatory strategy for complex
projects in coordination with our partners large and/or small
molecule combination products.
Manage execution of CMC documentation supporting IND/CTA,
NDA/BLA/MAA, post-approval supplements, annual reports and
responses to health authority questions per established business
Manage a regulatory team responsible for human factors study
design, execution and reporting for medical device and combination
products, including planning and managing HF team and studies
(formative, validation), and related documentation according to FDA
guidelines and applicable global standards
Work closely with cross-functional management involved with
R&D, QA, Operations, HR, Legal, Marketing, and Sales to develop
and implement regulatory strategies which position West products
for use in pharmaceutical applications.
Directly engage global regulatory bodies, Notified Bodies, etc.,
to resolve issues, provide guidance, and influence agency thinking
on global industry best practices affecting West products and
In partnership with Regulatory management the Director of
Regulatory Affairs must ensure compliance with global regulations
for design controls, cGMP, facility registration, device listing,
licenses, safety reporting, complaints, clinical trial
requirements, post-market surveillance, labeling, and permissible
Provide regulatory expertise and operational direction to
management, internal, and external customers to ensure conformance
and compliance with corporate requirements, government regulations,
guidelines and industry standards.
Review changes in international laws and regulations and assess
their impact and make recommendations to ensure compliance of
Work closely with RA management to successfully achieve cross
functional departmental and enterprise objectives.
Provide regulatory representation on project steering teams, as
Review technical project documentation, certifications,
correspondences, and external communications, as needed, providing
guidance and direction where applicable.
Independently develop and perform specific objectives and manage
highly complex work assignments to achieve personal objectives in
conformance with overall business goals.
Participate on and/or lead project teams for assigned projects
and communicate updates regarding regulatory guidance, directives,
policies, etc. in support of ongoing project/product
Proactively identify and champion process improvements within RA
and larger West teams.
Provide support in the development of business
Train, mentor and guide activities of direct reports, RA staff
members and peers to define and achieve personal, departmental and
Responsible for leading a team of regulatory and human factor
Education: Bachelor’s, Master’s or PhD in science related
Experience: Bachelor’s with 10+ years; or Master’s degree with
8-10 years or PhD with 7–8 years CMC regulatory
affairs/pharmaceutical experience in the area of combination
product development and registration.
Experience in leading Health Authority meetings (local and
international agencies) is highly preferred.
Experience in CMC regulatory with strong technical leadership
skills, as well as demonstrated understanding of related
pharmaceutical operations (e.g., manufacturing, process
development, analytical, quality assurance).
Demonstrated ability to manage multiple
tasks/projects/priorities and complex systems simultaneously is
Excellent interpersonal, communication and listening skills with
a proven record of working with and influencing multi-disciplinary
teams and external experts.
Capability to work effectively in matrix organizational
Demonstrated ability to collaborate and communicate across
cultures, organizational levels and disciplines.
Experience in Regulatory Affairs project management and
effective team leadership.
Practical experience in the development of human factor study
PHYSICAL & TRAVEL REQUIREMENTS:
5 - 10% (meetings, trainings, projects)
West is an equal opportunity employer and we value diversity at
our company. We do not discriminate on the basis of race, religion,
color, national origin, gender, sex, gender identity, sexual
orientation, age, marital status, veteran status, or disability
status. If you have a disability or special need that requires
accommodation, please send an email to email@example.com
. Where permitted by law, an offer of employment with West
Pharmaceutical Services, or any of its subsidiary or affiliate
companies, is contingent upon the satisfactory completion of
background screening and/or a pre-employment drug screening.