Key Facts

Remote From:

Africa

Category: Regulatory Affairs Manager

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Trials Project Management Cross-Functional Collaboration Clinical Trial Management Systems Process Optimization Veeva VBScript (Visual Basic Scripting Edition) Power BI Customer Marketing Empowerment

Other Skills

•
Microsoft Excel
•
Solutions Focused
•
Problem Solving

Roles & Responsibilities

University degree in a science discipline
Background in clinical trial management
Initial years of Regulatory Affairs experience working with Clinical Trial Applications in South Africa
Good level of knowledge of the CTA business

Requirements:

Manage the local submissions as Local Regulatory Contact (LRC)
Coordinate regulatory submissions in all participating countries as Regulatory Lead
Participate in Regulatory Operations meetings and project team meetings
Maintain relationships with other departments, clients, and regulatory agencies

Parexel

Pharmaceuticals

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.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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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 an experienced Senior Regulatory Affairs Professional 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 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
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
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.