Relicare Tech Services Offers Exciting Career Opportunities in Regulatory Affairs

Join Our Team as a Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs Specialist looking for a challenging role in an innovative and fast-growing company? Relicare Tech Services is actively hiring highly skilled professionals with expertise in dossier preparation and regulatory compliance for South Africa and international markets. This is an excellent opportunity to work with a dynamic team and contribute to the regulatory framework of life-changing pharmaceutical products.

Why Choose Relicare Tech Services?

At Relicare Tech Services, we believe in fostering an environment of growth, learning, and professional excellence. Our regulatory team is at the forefront of pharmaceutical compliance, dossier preparation, and regulatory documentation to ensure seamless approval of medicinal products. With a commitment to quality and accuracy, we offer an unparalleled work environment for ambitious regulatory professionals.

Key Responsibilities of a Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, you will play a crucial role in ensuring regulatory compliance and facilitating approvals across multiple regions. Your responsibilities will include:

📌 Dossier Compilation and Submission

✔ Prepare, compile, and review Common Technical Document (CTD/eCTD) dossiers in accordance with regulatory guidelines.
✔ Ensure that all documents meet the required standards for electronic submissions (eCTD format).
✔ Prepare and submit high-quality electronic dossiers and manage variations as per regulatory updates.

📌 Regulatory Compliance & Documentation

✔ Maintain up-to-date knowledge of South African and global regulatory requirements.
✔ Ensure all documentation complies with Drug Master Files (DMFs), Certificates of Suitability (CEPs), and product labeling regulations.
✔ Implement regulatory strategies to facilitate smooth approvals for new drug applications and post-market modifications.

📌 Communication with Regulatory Agencies

✔ Act as a primary liaison between Relicare Tech Services and regulatory authorities.
✔ Address and manage regulatory queries in a timely and professional manner.
✔ Collaborate with international regulatory bodies to ensure global compliance.

📌 Cross-functional Collaboration

✔ Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure regulatory documentation accuracy.
✔ Provide regulatory support during product development, submission, and post-market surveillance.
✔ Conduct internal audits to ensure continuous regulatory adherence.

Candidate Profile: What We Are Looking For

To excel in this role, we seek candidates with the following qualifications and expertise:

✅ Educational Background: B. Pharm / M. Pharm with proven Regulatory Affairs experience.
✅ Regulatory Knowledge: Strong understanding of South Africa’s MCC/SAPHRA regulatory guidelines and international compliance frameworks.
✅ Dossier Expertise: Hands-on experience in preparing CTD/eCTD dossiers and using electronic publishing tools for regulatory submissions.
✅ Analytical Skills: Ability to interpret and apply complex regulatory guidelines efficiently.
✅ Communication Excellence: Strong verbal and written communication skills for engaging with regulatory bodies and internal stakeholders.
✅ Attention to Detail: High level of accuracy in documentation and regulatory reporting.

Benefits of Working with Relicare Tech Services

🚀 Career Growth & Development

We prioritize professional development by offering continuous training programs, certifications, and workshops to keep you ahead in the regulatory field.

🌍 Global Exposure

Our regulatory team works on multi-country dossier submissions, providing exposure to South African, European, and other international regulatory markets.