Director, Regulatory Affairs

Director, Regulatory Affairs

Job Location: Danbury, Connecticut, USA | Fairfield, Connecticut, USA | Hartford, Connecticut, USA | Middlebury, Connecticut, USA | NewHaven, Connecticut, USA | NewHaven, Connecticut, USA | Southport, Connecticut, USA | Stamford, Connecticut, USA | Waterbury, Connecticut, USA | Washington, District of Columbia, USA | Dover, Delaware, USA | Wilmington, Delaware, USA | Atlanta, Georgia, USA | Portland, Maine, USA | Annapolis, Maryland, USA | Baltimore, Maryland, USA | Bethesda, Maryland, USA | Frederick, Maryland, USA | Gaithersburg, Maryland, USA | Hagerstown, Maryland, USA | Pikesville, Maryland, USA | Rockville, Maryland, USA | SilverSprings, Maryland, USA | Amherst, Massachusetts, USA | Boston, Massachusetts, USA | Foxboro, Massachusetts, USA | NewBedford, Massachusetts, USA | Salem, Massachusetts, USA | SouthBoston, Massachusetts, USA | Springfield, Massachusetts, USA | Wilmington, Massachusetts, USA | Worcester, Massachusetts, USA | Detroit, Michigan, USA | Manchester, New Hampshire, USA | Nashua, New Hampshire, USA | Portsmouth, New Hampshire, USA | Annandale, New Jersey, USA | AtlanticCity, New Jersey, USA | BaskingRidge, New Jersey, USA | Bridgewater, New Jersey, USA | Camden, New Jersey, USA | Central, New Jersey, USA | CherryHill, New Jersey, USA | EastBrunswick, New Jersey, USA | EastHanover, New Jersey, USA | Edison, New Jersey, USA | Elizabeth, New Jersey, USA | FlorhamPark, New Jersey, USA | JerseyCity, New Jersey, USA | JerseyShore, New Jersey, USA | Madison, New Jersey, USA | Matawan, New Jersey, USA | Morristown, New Jersey, USA | MountHolly, New Jersey, USA | NewBrunswick, New Jersey, USA | Newark, New Jersey, USA | Paramus, New Jersey, USA | Parsippany, New Jersey, USA | Paterson, New Jersey, USA | Piscataway, New Jersey, USA | Plainsboro, New Jersey, USA | Princeton, New Jersey, USA | Raritan, New Jersey, USA | Ridgewood, New Jersey, USA | Rutherford, New Jersey, USA | SanBernardino, New Jersey, USA | SouthNewJersey, New Jersey, USA | TomsRiver, New Jersey, USA | Verona, New Jersey, USA | Wayne, New Jersey, USA | WestWindsor, New Jersey, USA | Woodbridge, New Jersey, USA | Albany, New York, USA | Alden, New York, USA | Brentwood, New York, USA | Bronx, New York, USA | Brooklyn, New York, USA | Buffalo, New York, USA | GreatNeck, New York, USA | Hauppauge, New York, USA | Lancaster, New York, USA | LongIsland, New York, USA | Lynbrook, New York, USA | Manhattan, New York, USA | MidtownEast, New York, USA | NewYorkCity, New York, USA | Newburgh, New York, USA | Poughkeepsie, New York, USA | Queens, New York, USA | Rochester, New York, USA | StatenIsland, New York, USA | Syracuse, New York, USA | Utica, New York, USA | Webster, New York, USA | WhitePlains, New York, USA | Yonkers, New York, USA | Charlotte, North Carolina, USA | Durham, North Carolina, USA | Fayetteville, North Carolina, USA | Greensboro, North Carolina, USA | Greenville, North Carolina, USA | Raleigh, North Carolina, USA | RTP, North Carolina, USA | Wilmington, North Carolina, USA | Winston, North Carolina, USA | Allentown, Pennsylvania, USA | Bethlehem, Pennsylvania, USA | Conshohocken, Pennsylvania, USA | Croydon, Pennsylvania, USA | Doylestown, Pennsylvania, USA | Easton, Pennsylvania, USA | Erie, Pennsylvania, USA | Harrisburg, Pennsylvania, USA | Hatfield, Pennsylvania, USA | Hazelton, Pennsylvania, USA | Johnstown, Pennsylvania, USA | Lancaster, Pennsylvania, USA | NewCastle, Pennsylvania, USA | Philadelphia, Pennsylvania, USA | PhiladelphiaSouth, Pennsylvania, USA | Pittsburg, Pennsylvania, USA | PlymouthMeeting, Pennsylvania, USA | Scranton, Pennsylvania, USA | WestPhiladelphia, Pennsylvania, USA | Williamsport, Pennsylvania, USA | York, Pennsylvania, USA | Providence, Rhode Island, USA | Burlington, Vermont, USA | Alexandria, Virginia, USA | Arlington, Virginia, USA | Charlottesville, Virginia, USA | FallsChurch, Virginia, USA | Fredricksburg, Virginia, USA | Harrisonburg, Virginia, USA | Leesburg, Virginia, USA | Lynchburg, Virginia, USA | NewportNews, Virginia, USA | Norfolk, Virginia, USA | Reston, Virginia, USA | Richmond, Virginia, USA | Roanoke, Virginia, USA | VirginiaBeach, Virginia, USA | Washington, Virginia, USA | Williamsburg, Virginia, USA | Winchester, Virginia, USA

Job Requisition ID: 13504

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 it—where your skills and values drive our collective progress and impact.

• Responsible for establishing a product regulatory strategy for pharmaceutical products in the assigned therapeutic area
• Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
• Ensure that development and execution of product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestone, and activities for agency filing
• Ensures regulatory deliverables are in place and delivered to time cost and quality pre- and post-approval dossier management. Ensures that data are identified, obtained, and effectively presented for successful filing, approval, registration, market launch, maintenance of business and regulatory compliance.
• Active member of 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
• Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections
• Provide regulatory guidance/input to internal product review boards
• Manage assigned personnel if applicable
• Position is primarily remote. Candidates must be available to work onsite at our Bridgewater, NJ office one Tuesday–Thursday per month
• Occasional travel may be required

• Bachelor’s degree in science or health related field
• 10 years relevant pharmaceutical industry and regulatory experience
• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle
• Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical 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 pharmaceutical products

The range of starting base pay for this role is 176K-243K. 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 a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.