Regulatory Affairs contract role - Remote Work Immediate Joiners only

Role & responsibilities

Regulatory Affairs Associate

Description:

The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision.

Accountabilities/Responsibilities:

• Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches
• Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals
• Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation
• Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser
• Provide guidance and knowledge sharing within the RAM skill group
• If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc.

Minimum Requirements Education and Experience

• Relevant qualification and/or experience in science
• Minimum 5 years of experience from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project management skills
• Experience in document management and tracking databases

Preferred Experience

• Some regulatory/medical/technical experience
• Knowledge of CLIENTbusiness and processes
• Some knowledge of CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools
• Experience of collaborating with people from locations outside of India, especially Europe and/or USA

Skills and Capabilities

• Good written and verbal communication skills in English
• Cultural awareness
• Proficiency with common document management tools
• Ability to work independently and as part of a team
• Focus on continuous improvement and knowledge sharing

Internal and External Contacts/Customers

• Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST)
• Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads)
• Marketing companies
• Health authorities
• External collaboration partners
• “client” Legal
• “CLIENT”vendors for translation, document authentication, etc.

Interested candidate Kindly drop your updated resume to below mail id

Nithya_kumar@persolkelly.com

Regards,

Nithya

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