As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
We are looking for an experienced Regulatory Affairs Professional with working knowledge of Clinical Trail 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 Regulatory Affairs Associate you will ensure the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients. You may act as a Project Lead or Work Stream Lead and in this role you will assure the work of the entire team or work stream is delivered on time and that it meets client’s quality expectations. You will succeed in this role because will bring your strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
Key Deliverables in the role:
Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
You may be involved in local, regional, and/or global projects
Skills and Experience required for the role:
University degree in a science discipline
Background in clinical trial management
1-2 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of 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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