Regulatory Affairs Compliance Administrator at Aspen Pharma Group

Job description

Role Purpose

This role is in the Regulatory team and the resource person will be mainly responsible and accountable to track, manage, co-ordinate requests for Investment and Divestment Projects.

Specific Outcomes / Accountability

• Logging and tracking of project requests for investment and divestment projects for all affiliates.
• Inform and assist Affiliates with incomplete requests.
• Manage and coordinate all tracking tools and ensure that they are correctly saved on relevant drives and networks.
• Liaise with relevant internal and external stakeholders for the collection of documentation.
• Review and provide requested data for the sites.
• Coordinate all requests and follow up until close out.
• Participate in Affiliate progress meetings to track progress of development from initiation through to submission and eventual registration of product.
• Drive various projects
• Due diligence follow-up and resolution with internal and external stakeholders to ensure timely and successful project submission to relevant Regulatory Authority.
• Generate relevant reports and metrics for projects

Requirements

Qualifications & Experience:

• BSc Graduate (Science an Advantage)
• 1 – 2 years’ experience in Pharmaceutical manufacturing site and regulatory affairs preferable
• Knowledge of CTD preferable
• Knowledge of project management techniques and tools preferable
• Basic to Intermediate Microsoft Office proficiency (excel and word)

Key Competencies:

• critical thinking and problem solving skills
• planning and organizing
• decision-making
• communication skills
• influencing and leading
• team work
• adaptability
• stress tolerance
• perseverance and patience
• willingness to work longer hours to accommodate time zone differences
• diplomatic
• accuracy
• learning Agility

Aspen Competencies:

• Performance Driven: Initiative, multi-tasking, result oriented, systems thinking, planning and organizational skills, focused.
• Accountability / Ownership: focus, visioning, cooperation, proactive, responsibility and accountability, resilience.
• Dealing with ambiguity Embrace Change: flexibility and tolerance for ambiguity, transition management, capacity for and resistance to stress, perseverance and tenacity.
• Communicates Effectively: Informal communication skills, active listening skills, writing skills, presentation skills, meeting facilitation, empathy,
• Takes Action with Integrity: personal responsibility, self-assurance, honesty, ethical conduct.