Manager, Regulatory Affairs
Company: Bausch + Lomb
Location: Rockville
Posted on: August 5, 2022
|
|
Job Description:
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health
company dedicated to protecting and enhancing the gift of sight for
millions of people around the worldfrom the moment of birth through
every phase of life. Our mission is simple, yet powerful: helping
you see better, to live better.Our comprehensive portfolio of over
400 products is fully integrated and built to serve our customers
across the full spectrum of their eye health needs throughout their
lives. Our iconic brand is built on the deep trust and loyalty of
our customers established over our nearly 170-year history. We have
a significant global research, development, manufacturing and
commercial footprint of approximately 12,500 employees and a
presence in approximately 100 countries , extending our reach to
billions of potential customers across the globe. We have long been
associated with many of the most significant advances in eye
health, and we believe we are well positioned to continue leading
the advancement of eye health in the future.**Position
summary:**The Regulatory Affairs CMC Manager independently manages
all regulatory CMC aspects of Bausch Health Company Pharmaceutical
products throughout their lifecycle with minimum supervision. This
includes Brand, Generics, OTC/Nutritionals, Dietary Supplements and
Medical Devices. The Manager is responsible for the regulatory CMC
strategy of all submissions and managing interactions with
regulatory authorities on CMC issues.**Key responsibilities** :+
Formulate, lead and drive CMC regulatory strategy for development
projects or marketed products with a focus on creativity and
innovation, maximizing the business benefit balanced with
regulatory compliance.+ Proactively communicate CMC regulatory
strategy, key issues and any other critical topics throughout the
life cycle to interdisciplinary project teams and to appropriate
management level in Regulatory Affairs, R, TechOps and Supply Chain
as appropriate in a timely manner.+ Lead and drive all CMC
submission activities (planning, authoring, reviewing,
coordination, submission) for assigned projects/products. Make
quality regulatory decisions, balancing risks and benefits.+
Identify as early as possible, the required documentation and any
content, quality and/or timeline issues. Negotiate the delivery of
approved technical source documents in accordance with project
timeline.+ Coordinate with Regulatory Operations to ensure timely
and accurate submissions to Regulatory Authorities.+ Support or
manage (with minimum supervision) interactions with FDA and other
health authorities on CMC issues.+ Provide regulatory support to
other company functions during Regulatory Authority inspections.+
Serve as Regulatory Affairs representative on facility/site Local
Change Management Boards.**Qualifications/experience:**+ Bachelors
degree in science, bio-chemical engineering, pharmacy or other
health related field.+ Advanced degree highly preferred ( MS,
Pharm. D., Ph.D. or equivalent)+ 6+ years pharmaceutical industry
and 3+ years relevant regulatory CMC experience.+ Knowledge of
pharmaceutical industry regulatory affairs CMC discipline
throughout the product lifecycle, with awareness of preclinical,
clinical, commercialization, and operations.+ Knowledge of current
and emerging issues and trends of the pharmaceutical regulatory
environment.+ Capability to react quickly to changes in the
regulatory environment and make strategic recommendations to
minimize risk to the business.+ Ability to interpret Regulatory
Authority policies and CMC guidance and correctly apply them as
appropriate in product development and post-approval activities.+
Ability to influence and partner with cross-functional teams.+
Ability to take innovative ideas from proof of concept to promote a
successful product regulatory CMC submission and increase
probability of regulatory approval.+ Ability to critically review
detailed scientific information and assess whether technical
arguments are presented clearly and conclusions are adequately
supported by data.**This position may be available in the following
location(s):** **[[location_obj]]**All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, or veteran status.Job Applicants should be
aware of job offer scams perpetrated through the use of the
Internet and social media platforms.To learn more please
readBausch+Lomb's Job Offer Fraud Statement
(https://valeant.icims.com/icims2/servlet/icims2?module=AppInert=download=224770=-1624416981)
.
Keywords: Bausch + Lomb, Rockville , Manager, Regulatory Affairs, Executive , Rockville, Maryland
Click
here to apply!
|