Sr Specialist, Regulatory Affairs

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Job Role:

Job Location:

Essential Duties and Responsibilities

• Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions.
• Responsible for managing regulatory Product Life Cycle activities for electronic Submissions.
• High Proficiency in managing end-to-end RIMS-Veeva Vault for eCTD/NeeS regulatory submissions.
• Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
• Perform quality control (QC) checks to ensure high quality submission with zero deficiency.
• Assist with the update of the publishing processes and SOPs.
• Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs.
• Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities.
• Will have to work independently with minimal support.
• Proactive tracking of submission status and progress of regulatory filings.
• Maintenance of Regulatory systems, trackers and databases.
  

Qualifications

• Bachelor’s Degree or equivalent with 5 or more years’ experience in regulatory electronic document management and/or electronic submission publishing.
• Must possess strong analytical thinking, and excellent organizational and communication skills.
• Candidate must be able to work in a team-oriented, fast-paced environment.
• Strong technical skills (ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases).
• Demonstrated leadership, coaching or mentoring skills.
• Excellent verbal and written English communication skills, suitable for multi-location working relationships.
• Demonstrated teamwork and collaboration skills.
  

Equal Employment Opportunity

Reasonable Accommodations

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