[Hiring] Senior Regulatory Affairs Manager @GE HealthCare

Role Description

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 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).

• 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 to ensure the correct data (and level of detail) 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.
• Proactively provide CMC related regulatory advice and assessment of impact to product dossiers in support of key brand CMC variations. Advise project teams accordingly.
• Support QA during audits and inspections as required.
• Keep updated on CMC related guidelines.

Qualifications

• 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 fields 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 injectable diagnostic or pharmaceutical products.
• Experience working within a matrix organization with strong interpersonal and influencing skills.
• 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 a fast-paced environment.
• Strong problem solving and negotiation skills.

Requirements

• We will not sponsor individuals for employment visas, now or in the future, for this job opening.
• For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 Annual.
• Compensation decisions are dependent on the facts and circumstances of each case.
• This position may also be eligible to earn performance-based incentive compensation, which may include cash bonus(es) and/or long-term incentives (LTI).

Benefits

• Medical, dental, and vision insurance.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.