Senior Regulatory Affairs Lead - CTA
Bloemfontein, South Africa Job ID R0000024548 Category Regulatory / Consulting Date Posted 06/28/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are looking for a Senior Regulatory Affairs Lead with working knowledge of Clinical Trial Applications (CTA) to join our team in South Africa! This role can be office based (Bloemfontein) or home based anywhere in South Africa.
As a Senior Regulatory Affairs Consultant, you will ensure the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients. You will bring your specialist knowledge of clinical trial submissions in Sub-Saharan countries. Aa s Senior Consultant you will provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You may act as an individual contributor, a workstream lead or provide overall project leadership. You will provide guidance to project team members on technical/process issues. You will be able to anticipate next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.
Key Deliverables in the role:
Manage the local submissions (as Local Regulatory Contact - LRC)
Coordinate the regulatory submissions in all participating countries as Regulatory Lead.
Regulatory submission of Clinical Trial in the region
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
You may lead or be involved in local, regional, and/or global projects
Guide and mentor junior team members
Skills and Experience required for the role:
University degree in a science discipline
Background in clinical trial management
5-8 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
Experience with clinical trial submissions in other Southern African Countries
Solid knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
Customer-oriented and autonomous
Fluency in English is a must along with the local language.
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