Senior Manager, Regulatory Affairs IVD and Companion Diagnostics, Global
Senior Manager, Regulatory Affairs IVD and Companion Diagnostics, Global
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Job Description
The Senior Manager Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives with limited management supervision. Develops and manages strategy for regulatory submissions for China Japan Australia and other markets in the region. Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas Precision Medicine Medical Affairs and Commercial organizations. Represents CDx Device RA on teams to negotiate influence and provide strategic advice to internal and external stakeholders. Support regulatory intelligence and policy activities in monitoring regulatory pathways legislation updates policies and initiatives that could impact clinical studies initial product submissions and marketed products. Support AbbVie at Regulatory Authority project-specific meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws regulations and regulatory guidance as well as all AbbVie policies and procedures.
Responsibilities:
- Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
- Assists with preparation of submissions supplements and correspondence with regulatory authorities Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Seeks expert advice and technical support as required for strategies and submissions.
- Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions
- Represents RA Device on product development teams Global Regulatory Product Teams and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
- Develops implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
- Represents RA Device on project initiatives with other groups to drive efficiencies across the company.
Qualifications :
- Required Education: Bachelors degree in pharmacy biology chemistry pharmacology or related subject.
- Preferred Education: Relevant advanced degree preferred.
- Required Experience: 10 years of industry experience with IVD companion diagnostics medical devices or combination products. 5 years in quality systems or cross-functional project management.
- Experience working in a complex and matrix environment.
- Strong communication skills both oral and written. Fluency in Mandarin Chinese preferred.
- Preferred Experience: 10 years of pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Specific experience on China CDx regulations and agency interactions preferred.
- Experience developing and implementing successful global regulatory strategies.
- Experience working with Health Authorities
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
