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 a Senior Regulatory Affairs Associate 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 Associate, 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 Associate, under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of Parexel and our clients. You may take up a client facing role with support from line management.
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
3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
Experience with clinical trial submissions in other Southern African Countries
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Customer-oriented and autonomous
Fluency in English is a must along with the local language.
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