Global Regulatory Affairs Manager Job in Morristown, New Jersey US

Global Regulatory Affairs Manager

The Global Regulatory Affairs Manager manages all regulatory aspects for the Rx branded products. Participates on the product development teams and manages marketed product maintenance by providing global regulatory guidance and strategy as well as US executional components. Interacts with FDA accordingly. May perform due diligence efforts on new product opportunities. Essential Duties and Responsibilities: Responsible for developing a global product regulatory strategy for assigned projects products Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product approval Develop a product regulatory timeline aligned to Bausch + Lomb's strategic goals in alignment with commercialization strategy with key regulatory milestones and activities for agency filing Act as a credible regulatory lead as a member of the product team ensure execution of regulatory strategy, provide advices and recommendations on regulatory activities necessary to support effective development and successful approval of product. Coordinate with Global Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities Review as appropriate: Clinical (IB, protocol, reports), Pre-Clinical and other Development data in regulatory submissions during development and for new drug application preparation . Participates and/or coordinate preparation of IND, Clinical Trial applications, Regulatory Meetings Documents ( Requests, Briefing Package, Communications) Liaise with Bausch + Lomb regional country-specific pharmaceutical regulatory affairs personnel for international submissions and registrations Provide regulatory guidance/input to internal product review boards Technical Competencies: Knowledge of pharmaceutical industry regulatory development activities. Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical products Knowledge of clinical development, including responsibilities for successful adherence to development milestones, marketing authorization, meeting facilitation, labeling negotiations, regulatory responses Understands regulatory issues related to product patent protection and exclusivity Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product regulatory activities Ability to influence and partner with cross-functional teams in a global pharmaceutical organization 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 Professional Competencies: Hands-on experience in preparing regulatory submissions during development and for marketing authorizations such as : IND and CTA. 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 Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world - from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.