Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

As we continue to grow, we are seeking a Senior Manager Regulatory Affairs who provides leadership oversight and accountability for pre and post-market regulatory strategies and translates those strategies into executable plans for the department/area of responsibilities and administer day-to-day Regulatory Affairs operations and manages or supports a team of managers and employees of different levels. The primary responsibility is to support base business operations and new product development projects within the Transfusion Medicine Business Unit but may also support other Business Units if the need arises based on Company priorities. This position can be based in Raritan, NJ or Rochester, NY. Remote work options will be considered.

• Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pending applications and resolve regulatory matters. Prepare and/or provide oversight to junior RA staff in the creation of submission content to meet regulatory agency expectations for BLA and/or 510(k) regulated products.

• Support base business activities, such as Annual Reports, BLA Supplements, Labeling reviews, GUDID and Change Management reviews for regulatory submission impact. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.

• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements, submission content, indications of risk and approximate timing for application review/approval for planning purposes. Supports both new product development and currently marketed product portfolio within the Transfusion Medicine Business Unit.

• Represent Ortho to US regulatory agencies and interact with International Health Authorities to expedite pending applications, resolve regulatory matters, and manage development and pre-submission meetings for regulatory submissions.

• Provide support, as needed, for routine bi-annual FDA inspections, Pre-Approval Inspections or European Notified Body Inspections.

• Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies.

• Development goals, such as webinars, review FDA website and articles, read journals, attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff.

• Frequently responsible for relationship management

• Ability to provide Regulatory leadership in a matrixed organization

• Monitor US Regulatory landscape for updates and changes to regulations and guidances specific to CBER regulated products.

• Provide Regulatory guidance to project teams in the design and operation of CBER licensed manufacturing facilities.

• Perform other work-related duties as assigned.

• Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience.

• Minimum of 10+ years experience in an FDA regulated drug, biologic or IVD industry required. Biologic/Device combination experience a plus.

• Minimum of 7+ years hands-on submission experience including the developing and execution of regulatory strategies for drug, biologic and/or IVD regulated products is required, specific experience in biologics is preferred, but not required.

• 5+ years of people management experience is desired.

• RAC (Regulatory Affairs Certification) is a plus.

• Knowledge of US drug and/or biologic regulations is required and an understanding of EU regulations would be a plus. Specific knowledge of biologic IVDs and biologic IVD/device combinations will be given preferential consideration.

• Experience supporting NDA and/or BLA post-market CMC sections is preferred.

• Experience developing regulatory strategies is required and an understanding of product development is a plus.

• Ability to demonstrate model behavior, understands priorities and encourages others to drive for results is needed.

• Ability to mentor junior level staff as well as cross-train with peers. Ability to work with business partners across geographies and time zones is needed.

• Demonstrated regulatory expertise developed through experience and positive track record is required.

• Excellent interpersonal, teamwork and verbal/written communication skills are required. Good organizational skills and an ability to manage multiple tasks/projects/priorities is required.

• Experience in supporting regulatory filings requiring Pre-Approval Inspections (PAI) would be a plus.

• Up to 10-15% travel, domestic and international, required.

Key working relationships:

• Internal partners: Must maintain excellent working relationships with Domestic Regulatory Affairs colleagues, Product Managers, Project Leaders, R&D, Operations, Global Publications, International Regulatory Affairs, Marketing, and Quality / Compliance partners.

• External partners: Regulators, External KOLs, MD/Cybersecurity Consultants, External manufacturers, vendors/suppliers, Trade Associations, Auditors

Colorado State Posting Details: This position's starting salary is between $99,000 and $198,000 per year, and it is bonus eligible. Salary will be determined by education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time) and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

EOE/AA Disability/Veteran

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