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Associate Director, Regulatory Affairs

Company: Bausch Health
Location: Baltimore
Posted on: January 16, 2022

Job Description:

Career Opportunities: Associate Director, Regulatory Affairs (6181) Requisition ID -6181 -- -Posted - -US RX/Consumer -- -R&D -- -US - Bridgewater, NJ -- - City (11) Bausch+Lomb 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+Lomb 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. - JOB TI T LE Associate Director Regulatory Affairs - Brand BUSINESS TITLE Associate Director Regulatory Affairs - Brand BAND MMT BUSINESS UNIT / FUNCTION US Regulatory Affairs JOB CODE LOCATION OBJECTIVES/ PURPOSE OF JOB The Associate Director Regulatory Affairs handles all regulatory development aspects for prescription brand ("Brand") and AGX products. Active member on the product development team to provide regulatory guidance for Pharmaceutical Brand and AGX products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for assigned products. May perform due diligence efforts on new product opportunities. KEY ACTIVITIES/ 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 organization defined product development, with key regulatory milestones, and activities for agency filing
  • Coordinate with the Labeling group 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 Regulatory Operations group to ensure timely and accurate submissions to Regulatory Authorities
  • Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical branded prescription products
  • Liaise with country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
  • Manage interactions with other functions (e.g., Quality, Compliance) during Regulatory Authority inspections
  • Provide regulatory guidance/input to internal product review boards
  • Manage assigned personnel
  • Occasional travel may be required SUPERVISE DIRECT REPORTS Yes, as applicable SCOPE OF POSITION US KEY RELATIONSHIPS
    • Demonstrated ability in analytical reasoning and critical thinking skills
    • Strong capability to contribute and lead a team environment
    • 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
    • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
    • Focused ability to influence operational excellence and performance metrics
    • Risk adverse where needed with the ability to identify potential solutions to complex problems QUALIFICATIONS/ TRAINING
      • Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
      • Knowledge of domestic 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 activities for Brand and AGX products
      • Ability to influence and partner with cross-functional teams in a pharmaceutical organization
      • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy 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 EXPERIENCE
        • 10+ years relevant pharmaceutical industry and regulatory experience
        • Pharmaceutical Rx development strategy experience highly preferred
        • Bachelor's degree in science or health related field --- 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+Lomb's Job Offer Fraud Statement .

Keywords: Bausch Health, Baltimore , Associate Director, Regulatory Affairs, Executive , Baltimore, Maryland

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