TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Sr. Manager, Regulatory Affairs

Company: Bausch Health
Location: Bridgewater
Posted on: April 8, 2021

Job Description:

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 timeline.
  • 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. Qualifications:
    • 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 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 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.
    • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
      Self-motivated, detail-oriented and capable of working independently.
    • Demonstrated ability in analytical reasoning and critical thinking skills.
    • 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 situations
    • 8+ years pharmaceutical industry and 6+ relevant regulatory CMC experience.
    • 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 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 read--Bausch Health's Job Offer Fraud Statement .

Keywords: Bausch Health, Trenton , Sr. Manager, Regulatory Affairs, Executive , Bridgewater, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Area Director
Description: Job Purpose or Summary:In alignment with the company mission, vision and values, the Area Director is responsible for achieving the revenue and profit goals for his/her office. Manage day-to-day operations, (more...)
Company: Arosa
Location: Hackensack
Posted on: 04/14/2021

Manager, Ad Partnerships
Description: Job Summary:The Ad Partnerships team is responsible for advancing the premium ad experience and future growth of Disney Advertising Sales through 1 Establishing optimal partner terms, policies, and (more...)
Company: Disney Media & Entertainment Distribution
Location: Freeport
Posted on: 04/14/2021

Manager, Product Management - Ad Platform (Campaign Lifecycle)
Description: Job Summary:DMED Ad Platforms is responsible for delivering global adverting technology solutions for Disney's Linear and Addressable channels, brands and streaming services. With unmatched scale, premium (more...)
Company: Disney Media & Entertainment Distribution
Location: Hicksville
Posted on: 04/14/2021


Consumer and Real Estate Lending Manager
Description: This website is AudioEye enabled and is being optimized for accessibility.
Company: Everence
Location: Lancaster
Posted on: 04/14/2021

Family Practice in PA - Associate Director for Core Faculty Team Needed in Pennsylvania
Description: Medical Director opening in Lancaster, Pennsylvania. This and other physician jobs brought to you by DocCafe.com CompHealth is assisting an osteopathic faculty team in Pennsylvania with their search for (more...)
Company: CompHealth
Location: Lancaster
Posted on: 04/14/2021

Project Manager/Client Services Rep
Description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier (more...)
Company: Eurofins USA
Location: Lancaster
Posted on: 04/14/2021

Relationship Manager
Description: If you thrive on creating strong, value-add business relationships while ensuring the best possible customer experience, we are looking for you. Through your skills in training, issue resolution, workflow (more...)
Company: First Source Title Agency, Inc
Location: Hoboken
Posted on: 04/14/2021

Shift Manager- Wendy's Restaurants
Description: Movin on up Families come in all shapes and sizes. And that includes the Wendy s family - the people you work with as a Wendy s Shift Manager.The stuff you want - like fun people, quality food, and a (more...)
Company: Wendy's
Location: West Babylon
Posted on: 04/14/2021

Salon Manager - Commerce Center
Description: Salon Manager Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: New Brunswick
Posted on: 04/14/2021

Lifestyle360 Program Director
Description: Lifestyle360 Program Director At Morningside of Lancaster Apply Now Location Information Morningside of Lancaster is a beautiful community in Lancaster, SC, with more than 50 units offering assisted (more...)
Company: Five Star Senior Living
Location: Lancaster
Posted on: 04/14/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds