MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion
Manager, Regulatory and Strategic Development
POSITION SUMMARY:
The candidate will be responsible for developing andimplementing and regulatory strategies for client products (Drugs and Devices).Responsible for the strategy and preparation of regulatory submissions for theUS FDA, EU and ROW regulatory authorities. The position will include client andregulatory authority liaison. The position will include the supervision andmanagement of regulatory professionals and support personnel.
Job Duties and Responsibilities:
• Create, monitor and maintain timelines for clientstrategic development, submission management and regulatory affairs programs.
• Establish and direct cross-functional teams of internaland external personnel to deliver client projects.
• Pharma: Familiarize with clinical, non-clinical, andCMC development plans to suggest strategies and plan to pharma / biotechclients
• Devices & Diagnostics RA functions
• Support Regulatory Operations / Submission managementAutomation efforts
• Provide training for in-house personnel and supervisethe assigned Regulatory staff as needed.
• Prepare technical content for regulatory submissionsand manage regulatory projects as required by directing the team.
• Monitors activities of applicable regulatory agenciesand industry organizations to identify any changes in regulations andcommunicates to appropriate personnel. Shows an understanding of the changing regulatory environment and theimpact on business practices, policies and projects and demonstrates an abilityto discuss relevant points in a diverse forum in more general terms.
Supervisory Responsibilities:
• Directly supervises employees assigned. Carries outsupervisory responsibilities in accordance with the organization’s policies andapplicable laws. Responsibilities include interviewing, hiring and trainingemployees; planning, assigning and directing work; appraising performance;rewarding and disciplining employees; addressing complaints and resolvingproblems.
Other:
• Ability to perform business travel (local /international), up to 25%
• All other projects as assigned
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awarded as:
• BestBiopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
• BestPharmaceutical Strategic Development Specialist - UK Enterprises
• TheOutstanding Consulting Firm - Insights Success
• AI Excellencein Regulatory & Automation Solutions - Acquisition International
• AIExcellence in Best Bio Pharma Development Partner - Acquisition International
• BestPractices Award - Clinical Informatics
• NJExcellence Award - US Institute for Excellence in Commerce
• BestBiotech Award - US Commerce Association
• Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards
• Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP
• MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company& TOP 100 diversity business in NJ
• MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.