Regulatory Affairs Associate (FTC)

Novartis; Midrand; On-site; ZAR 400,000 - 700,000; Full time

Job summary

A leading pharmaceutical company seeks a Regulatory Specialist to support product registration and ensure compliance with local regulations. Candidates should possess a BPharm degree and 3-5 years of regulatory experience. Responsibilities include maintaining product licenses, reporting complaints, and fostering stakeholder relations. Join a mission-driven environment focused on improving lives.

Qualifications

• Registered with the SAPC.
• Minimum 3-5 years of regulatory experience.
• Ability to create and submit eCTDs.

Responsibilities

• Achieve optimal product registration and maintain product licenses.
• Ensure compliance with local regulations and company strategies.
• Report technical complaints and adverse events within 24 hours.

Skills

Analytical skills

Collaboration

Detail-oriented

Lifesciences knowledge

Project planning

Regulatory compliance

Education

BPharm Degree

Tools

Adobe Acrobat

Job description

Contributes to and supports the development of submissions for product registration, including progress reports, supplements, amendments, and periodic experience reports. Supports all registration activities of the Department to ensure compliance with the local pharmaceutical regulatory environment.

Job Description

Major accountabilities :

• Achieve optimal product registration with commercially attractive labeling in accordance with the registration plan.
• Maintain and secure product licenses in terms of CMC / CDS / safety updates, according to local regulations, laws, guidelines, company strategy, and global compliance.
• Ensure compliance with Fuse BeSure code of conduct, relevant regulations, and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, drug safety reporting, etc.).
• Foster and maintain good relations with internal and external stakeholders.
• Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

Minimum Requirements :

Registered with the SAPC. Min BPharm Degree.

Work Experience :

• Regulatory experience of at least 3-5 years. Ability to create and submit eCTDs.
• Functional breadth and cross-cultural experience.
• Operations management and execution.
• Project management skills.

Skills :

• Analytical skills.
• Collaboration.
• Detail-oriented.
• Lifesciences knowledge.
• Project planning.
• Regulatory compliance.

Languages :

• English.

Why Novartis :

Our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. Join us and be part of this mission! Learn more about our benefits and rewards in the Novartis Life Handbook. We are committed to building an inclusive work environment and diverse teams that reflect the patients and communities we serve.

Join our Novartis Network to stay connected and hear more about our career opportunities, even if this role isn't suitable for your experience or career goals.

Desired Skills :

Analytical skills, clinical trials experience, collaboration, detail-oriented, lifesciences, project planning, regulatory compliance.

Required Experience :

Proofreading, Adobe Acrobat, FDA regulations, manufacturing & controls, biotechnology, clinical trials, research & development, GLP, cGMP, product development, chemistry, writing skills.

Employment Type : Full-Time

Vacancy : 1