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Job Id 34527409
Title Sr.Manager, Regulatory Operations
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description

MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion


Sr.Manager, Regulatory Operations

POSITION SUMMARY:          
The candidate will be responsible for developing and implementing and regulatory operations planning and execution for client products (Drugs and Devices). Responsible for the strategy and preparation of regulatory submissions for the US FDA, EU and ROW regulatory authorities. The position will include the supervision and management of regulatory operations team and support personnel.


Job Duties and Responsibilities:
• Create, monitor and maintain timelines for strategic development, submission management, publishing and regulatory operations programs.
• Establish and direct cross-functional teams of internal and external personnel to deliver client projects.
• Pharma: Familiarize with clinical, non-clinical, and CMC development plans to suggest strategies and plan to pharma / biotech clients
• Devices & Diagnostics REg Ops functions
• Support Regulatory Operations / Submission management Automation software efforts as REg Ops SME
• Provide training for in-house personnel and supervise the assigned Regulatory staff as needed.
• Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations and communicates to appropriate personnel.  Shows an understanding of the changing regulatory environment and the impact on business practices, policies and projects and demonstrates an ability to discuss relevant points in a diverse forum in more general terms. 


Supervisory Responsibilities:
• Directly supervises employees assigned. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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 and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, 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:
•             Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
•             Best Pharmaceutical Strategic Development Specialist - UK Enterprises
•             The Outstanding Consulting Firm - Insights Success
•             AI Excellence in Regulatory & Automation Solutions - Acquisition International
•             AI Excellence in Best Bio Pharma Development Partner - Acquisition International
•             Best Practices Award - Clinical Informatics
•             NJ Excellence Award - US Institute for Excellence in Commerce
•             Best Biotech Award - US Commerce Association
•             Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
•             Circle Of Excellence – MerchantCircle


About MakroGroup | www.MakroGrp.com

Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.

•             MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
•             DDi Awarded 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 CSR Initiative, has counseled over 3000 people.


Qualification
Experience 10-15 Years
Job Category Regulatory Affairs
Posted On 10/22/2021
Expires On 11/22/2021
 
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