Sr. Manager, Regulatory Affairs
Company: Bausch Health
Posted on: April 8, 2021
Career Opportunities: Sr. Manager, Regulatory Affairs (CMC)
(4096) Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global
company that develops, manufactures and markets a range of
pharmaceutical, medical device and over-the-counter products,
primarily in the therapeutic areas of eye health, gastroenterology
and dermatology. We are delivering on our commitments as we build
an innovative company dedicated to advancing global health. Each
day, Bausch Health products are used by over 150 million people
around the world. Our approximately 21,000 employees are united
around our mission of improving people's lives with our health care
products, and we manufacture and market health care products
directly or indirectly in approximately 100 countries.-- Senior
Manager, Regulatory Affairs - CMC The Regulatory Affairs - CMC
Senior Manager independently manages all regulatory CMC aspects of
Bausch Health Company pharmaceutical products throughout their
lifecycle. This includes Brand, Generics, OTC/Nutritionals, Dietary
Supplements and Medical Devices. The Senior Manager is responsible
for the regulatory CMC strategies of all submissions for products
under his/her responsibility as well as managing interactions with
regulatory authorities on CMC issues. 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&D, 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
- Coordinate with Regulatory Operations to ensure timely and
accurate submissions to Regulatory Authorities.
- Manage interactions with FDA 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.
- Participate in assigned due diligent business activities.
- Review and provide input on proposed health authority guidance
documents on CMC issues.
- Other job responsibilities as needed Formulate, lead and drive
CMC regulatory strategy for development and marketed products. Lead
and drive all CMC submission activities (planning, authoring,
reviewing, coordination, submission). Lead FDA or other Health
Authority interactions on CMC issues. Internal business functions
relating to developing regulatory CMC strategies, CMC submission
activities and health authority interactions on CMC issues.
- 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
- Ability to influence external regulatory stakeholders and shape
the external regulatory environment.
- 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
- 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.
- Ability to assess project risks, and where appropriate,
recommend contingency plans and strategies to mitigate regulatory
Self-motivated, detail-oriented and capable of working
- Demonstrated ability in analytical reasoning and critical
- Strong business acumen and ability to see the business drivers
outside of Regulatory Affairs.
- Excellent communication skills; both oral and written.
- Strong interpersonal skills with the ability to influence
others in a positive and effective manner.
- Demonstrated ability to contribute to a continuous learning and
process improvement environment
- Capacity to react quickly and decisively in unexpected
- 8+ years pharmaceutical industry and 6+ relevant regulatory CMC
- Bachelor's degree in science, bio-chemical engineering,
pharmacy or other health related field.
- Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or
equivalent) This position may be available in the following
location(s): US - Bridgewater, NJ
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or veteran
Job Applicants should be aware of job offer scams perpetrated
through the use of the Internet and social media platforms.
To learn more please read--Bausch Health's Job Offer Fraud
Keywords: Bausch Health, Trenton , Sr. Manager, Regulatory Affairs, Executive , Bridgewater, New Jersey
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