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Senior Regulatory Affairs Associate - CTA

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
South Africa

Offer summary

Qualifications:

University degree in a science discipline, 3-5 years of Regulatory Affairs experience, Knowledge of Clinical Trial Applications, Experience with clinical trial submissions in Southern Africa.

Key responsabilities:

  • Manage local regulatory submissions
  • Coordinate regulatory submissions in participating countries
  • Participate in project team meetings
  • Guide and mentor junior team members
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsClinical TrialsClinical Data ReviewProject ManagementVBScript (Visual Basic Scripting Edition)Power BIVeevaClinical Trial Management Systems

Other Skills

  • Microsoft Excel
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