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Project Manager

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Company Profile	Abbott Limited
Job ID Number	44824
Job Title	Project Manager
Job Location	Maidenhead, Berks
Apply	Ring Ruth on her direct line 01494 818 037 or you can apply online:
Job Description	Role:Project Manager Compliance & Regulatory Affairs Location: Maidenhead Berkshire -Identifies/obtains data needed, and ensures that they are effectively presented for the registration of Products, eg CMC, Clinical and labeling Project Manager -Assesses scientific data provided by specialist units for registration purposes against regulatory requirements -Manages the preparation of registration packages (including complex) and answers to deficiency letters -Ensures records of filings and approvals are maintained -Approves the complete regulatory data packages prior to filing and during the approval process -Prepares agency meeting packages, and develops strategies for agency meetings - Represents Regulatory Affairs at relevant meetings e.g. Brand team, Product Workstream, CMC Workstream and presents agreed RA position and negotiates with and influences management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements - Monitor actual vs. planned activities and timelines. - Identify issues impacting project progression. -Participates in agency meetings as appropriate -Trains, develops and mentors individuals; may include formal supervisory responsibilities Assesses and approves manufacturing change requests (if relevant to role) and updates filings accordingly -Assures investigational product submissions are updated appropriately throughout the development phase (where appropriate) -Maintains awareness of regulatory legislation and assesses its global impact on business and Abbott EPD RA -Works to assure products remain in compliance Licensing Reviews
Person Profile	Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject Previous experience in Regulatory Affairs
Job Package	TBC
Interview Process	TBC

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Ruth
Account Manager
for this opportunity
01494 818 037
(Mon to Fri 0830 to 1800 hours)
Ruth@zenopa.com

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