Regulatory Affairs Manager

The Focus Group; Johannesburg; On-site; ZAR 600 000 - 900 000; Full time

Job summary

A leading pharmaceutical multinational is seeking a Regulatory Affairs Manager in Johannesburg. The role involves managing regulatory activities, maintaining product registrations, and collaborating with health authorities. Ideal candidates will have 4-6 years of regulatory experience in a multi-national setting, with strong negotiation and problem-solving skills.

Qualifications

• 4 - 6 years Regulatory experience in a multi-national Pharmaceutical company.
• Significant experience with Regulatory Authorities.
• People management experience is an asset.

Responsibilities

• Manage local Regulatory Affairs activities in compliance with business priorities.
• Maintain product registrations and RA databases.
• Collaborate with local health authorities.

Skills

Strong business acumen

Operational excellence

Innovative thinking

Effective negotiation skills

Cross-functional collaboration

Problem solving

Project management

Presentation skills

Time management

Education

Bachelors in Pharmacy

Masters in Pharmacy

Job description

Client: Pharmaceutical Multinational

We are hiring a Regulatory Affairs Manager responsible for the management and execution of regulatory activities for South Africa (with extension into SSA). The job holder performs quality regulatory activities in compliance with internal and external requirements to support business continuity.

The job holder will be based in Johannesburg, South Africa and will report to the Head of Regulatory Affairs.

Job Responsibilities:

• Timely execution and management of local Regulatory Affairs activities in compliance with Regional RA strategies and local business priorities.
• Maintain product registrations and RA databases while ensuring business continuity in compliance with internal and external regulations and requirements.
• Collaborate with local health authorities to support CLIENTS’s business in the operating unit
• Provide regular intelligence on changes in regulatory environment, competitor activity and opportunities to enable the business realize risk or opportunities arising in the RA environment.
• Participate in budget exercises and collaborate cross-functionally and ensure all stakeholders are updated on relevant RA topics.
• Establish a strong partnership and interact with the local authorities in the country; Maintain efficient relationships with related Regulatory service Providers (local agents and vendors).
• Conduct agreed actions for local projects.
• Provide support to the country RA head on local, regional and global projects.

Job Requirements:

• Bachelors in Pharmacy / Masters is an advantage
• 4 - 6 years Regulatory experience in a multi-national Pharmaceutical company; Human Pharma experience preferred.
• Significant experience of direct interactions with Regulatory Authorities.
• People management experience is an asset.
• Regional or International working experience is a plus.

Skills:

• Strong business acumen and operational excellence
• Innovative and critical thinking
• Effective negotiation skills
• Demonstration of effective cross-functional collaboration
• Problem solving and Decision making
• Project management
• Good Presentation skills
• Time management

Registered body: SAPC or South African Pharmacy Council

Desired Skills:

• Healthcare
• Management
• Medical
• Negotiation
• Pharmaceutical
• Presentations
• Regulatory Rules