(Senior) Manager Regulatory Affairs (a)

Depending on the experience level of the candidate, the responsibilities are as follows:

• Coordinate the preparation, submission, management and maintenance of submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: CTAs, amendments and requests for information, Orphan drug applications, Paediatric Investigation Plans and Annual Reports
• Life cycle maintenance activities for marketed products including management information updates and assessment of promotional materials.
• Collaborate with key internal stakeholders to ensure the regulatory strategy is incorporated and implemented in line with product development objectives.
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation.
• Collaborate with cross-functional teams to ensure alignment on regulatory requirements.
• Manage and track queries and commitments with regulatory agencies,collaborate with subject matter experts to respond to queries, provide updates regarding regulatory submissions, conditions/commitments.
• Manages regulatory documents in internal Regulatory Information Management system including tracking submissions and archiving.
• Provide representation for study-level regulatory activities and participate in cross-functional project teams and product development activities/meetings.
• Perform research to support the development of regulatory strategy for the assigned clinical development programs.