Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls in Fredericton

The Senior Regulatory Manager provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics. The key responsibility of the Senior Regulatory Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product (Module 2.3 and Module 3).

Key Responsibilities include:

• To provide CMC related strategic regulatory input for the assigned projects/products.
• Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package.
• Review and approve published output.
• In conjunction with the Global Regulatory Lead (GRL), guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
• Review and, if necessary, write and edit individual CMC submission documents/CMC dossier sections to support regulatory submissions.
• Maintain registration tracking information and assist in the development of good document management practice standards.
• Work closely with global RA and regional RAs to address questions from regulatory authorities.
• In support of key brand CMC variations, proactively provide CMC related regulatory advice and assessment of impact to product dossiers. Advise project teams accordingly.
• To support QA during audits and inspections as required.
• To keep oneself updated on CMC related guidelines.

Qualifications/Requirements:

• Bachelor's Degree and 6+ years of experience.
• Experience in a diagnostic, pharmaceutical, or medical device industry.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Demonstrated experience of operating in a highly-regulated environment.
• Capable of applying analytical skills in a CMC regulatory environment.
• Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences.
• Experience in electronic document management and Quality management systems.
• Knowledge of international CMC regulatory requirements.

Desired Characteristics:

• Master's Degree.
• Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products.
• Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines.
• Has the capability to influence managers and help drive decisions at a project level.
• Experience with Veeva RIM or other registration tracking tools.
• Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
• Strong problem solving and negotiation skills.

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.