Bausch Health Companies Inc.
Associate Director, Regulatory Affairs
Bausch Health Companies Inc., Bridgewater, Massachusetts, us, 02324
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Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.
Responsibilities:
Responsible for developing a product regulatory strategy for pharmaceutical products Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development Develop a product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestone, and activities for agency filing Coordinate with the Labeling Lead for the development/maintenance of product labels Ensure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical products. Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input within business development and due diligence opportunities. Preparation of yearly plan activities and regulatory budget proposal, when necessary, based on business plans. Other activities and tasks within RA area as assigned by Supervisor. Manage assigned personnel if applicable Position is primarily remote. Candidates must be available to work onsite at our Bridgewater, NJ office one TuesdayThursday per month Occasional travel may be required
Qualifications:
Minimum 6 years relevant pharmaceutical industry and regulatory experience; Pharmaceutical Rx experience highly preferred Bachelors degree in science or health related field Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance that affect Brand products Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory Regulatory Affairs Certification by RAPS a plus
The range of starting base pay for this role is 165K - 226K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bausch Health Companies Inc. by 2x Sign in to set job alerts for “Associate Director Regulatory Affairs” roles.
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Associate Director, Regulatory Affairs
role at
Bausch Health Companies Inc. Continue with Google Continue with Google Join to apply for the
Associate Director, Regulatory Affairs
role at
Bausch Health Companies Inc. Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices
Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.
Responsibilities:
Responsible for developing a product regulatory strategy for pharmaceutical products Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development Develop a product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestone, and activities for agency filing Coordinate with the Labeling Lead for the development/maintenance of product labels Ensure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical products. Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input within business development and due diligence opportunities. Preparation of yearly plan activities and regulatory budget proposal, when necessary, based on business plans. Other activities and tasks within RA area as assigned by Supervisor. Manage assigned personnel if applicable Position is primarily remote. Candidates must be available to work onsite at our Bridgewater, NJ office one TuesdayThursday per month Occasional travel may be required
Qualifications:
Minimum 6 years relevant pharmaceutical industry and regulatory experience; Pharmaceutical Rx experience highly preferred Bachelors degree in science or health related field Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance that affect Brand products Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory Regulatory Affairs Certification by RAPS a plus
The range of starting base pay for this role is 165K - 226K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Bausch Health Companies Inc. by 2x Sign in to set job alerts for “Associate Director Regulatory Affairs” roles.
Continue with Google Continue with Google Continue with Google Continue with Google Piscataway, NJ $170,000 - $200,000 1 week ago Bridgewater, NJ $95,000 - $130,000 2 months ago Piscataway, NJ $170,000 - $200,000 4 days ago Senior Manager, Global Regulatory Affairs Labeling
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Morristown, NJ $147,000.00 - $212,333.33 6 days ago Princeton, NJ $91,000.00 - $113,700.00 2 weeks ago Senior Scientist/Associate Director, Regulatory Affairs CMC
Global Regulatory Affairs Compliance and Planning, Sr. Manager
Princeton, NJ $155,000.00 - $170,000.00 1 week ago Titusville, NJ $168,000.00 - $271,400.00 2 weeks ago Manager - Regulatory Affairs - Therapeutic Area
Plainsboro, NJ $135,000.00 - $160,000.00 3 weeks ago Raritan, NJ $168,000.00 - $271,400.00 2 weeks ago CDx Associate Director, Global Regulatory Affairs
Livingston, NJ $74,100.00 - $147,800.00 3 days ago CDx Associate Director, Global Regulatory Affairs
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Hackettstown, NJ $133,067 - $182,958 6 days ago Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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