Regulatory Affairs - Hematology |
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Job Type: | NA | | Classification: | Executive Positions |
Company | Griffin Associates | | Advertiser Type: | Company |
Country: | United States | | Location: | Boston |
Language: | English | | Contact Name: | |
Job Adress: | Boston | | Telephone: | |
Position: Regulatory Affairs - Hematology |
Description: Director, Regulatory Affairs, Hematology
Description
1) Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2) Foster and maintain relationships with regulatory authorities to facilitate interactions
3) Ensure alignment of regulatory strategy to business strategy across all functional areas
4) Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5) Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6) Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7) Act as business liaison to a portfolio, region, or business unit
8) Develop and manage budget
9) Act as primary contact with the regulatory authorities including the planning and le
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