Pharmaceutical Regulatory Affairs Manager

Placements24; Vereeniging; On-site; ZAR 1,200,000 - 1,900,000; Full time

Job summary

Placements24 in Vereeniging seeks a strategic Pharmaceutical Regulatory Affairs Manager to lead regulatory compliance across product lifecycles. You will develop global regulatory strategies, oversee dossier submissions to SAHPRA, and liaise with health authorities to secure timely approvals.

The role requires a strong background in regulatory affairs, cross-functional collaboration with R&D, clinical, and manufacturing teams, and leadership to mentor professionals in a growing pharmaceutical

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field; advanced degree preferred.
• Minimum of 7 years of experience in pharmaceutical Regulatory Affairs.
• Proven success in managing regulatory submissions for various product types (e.g., small molecules, biologics).
• In-depth knowledge of pharmaceutical regulations and guidelines in key markets.
• Excellent strategic thinking, project management, and communication skills.
• Experience working with cross-functional teams, including R&D, clinical, and manufacturing.

Responsibilities

• Develop and execute global regulatory strategies for product registration and lifecycle management.
• Prepare and submit regulatory dossiers to health authorities (e.g., SAHPRA, FDA, EMA) for new drug applications and variations.
• Liaise with regulatory agencies, responding to queries and ensuring timely approvals.
• Monitor and interpret evolving regulatory landscapes and provide strategic guidance to the organization.
• Oversee the review of promotional materials and labeling to ensure regulatory compliance.
• Manage and mentor a team of regulatory affairs professionals.

Skills

Regulatory strategy

Project management

Stakeholder communication

Cross-functional collaboration

Leadership

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Life Sciences

Advanced degree

Job description

About the Role

Our client is seeking a dynamic and strategic Pharmaceutical Regulatory Affairs Manager to lead their regulatory compliance efforts in Vereeniging . This senior position involves overseeing all aspects of regulatory submissions, interactions with health authorities, and ensuring adherence to national and international pharmaceutical regulations. You will be responsible for developing regulatory strategies that support the company's product lifecycle, from development through to post-market surveillance. This is an ideal opportunity for a seasoned regulatory professional to shape the future of our client's product portfolio and contribute to market access for vital medicines.

Key Responsibilities

• Develop and execute global regulatory strategies for product registration and lifecycle management.
• Prepare and submit regulatory dossiers to health authorities (e.g., SAHPRA, FDA, EMA) for new drug applications and variations.
• Liaise with regulatory agencies, responding to queries and ensuring timely approvals.
• Monitor and interpret evolving regulatory landscapes and provide strategic guidance to the organization.
• Oversee the review of promotional materials and labeling to ensure regulatory compliance.
• Manage and mentor a team of regulatory affairs professionals.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 7 years of experience in pharmaceutical Regulatory Affairs .
• Proven success in managing regulatory submissions for various product types (e.g., small molecules, biologics).
• In-depth knowledge of pharmaceutical regulations and guidelines in key markets.
• Excellent strategic thinking, project management, and communication skills .
• Experience working with cross-functional teams, including R&D, clinical, and manufacturing.

Benefits

• Highly competitive salary and executive bonus potential.
• Comprehensive benefits package including medical, dental, and retirement plans.
• Generous vacation and paid time off allowances.
• Opportunities for leadership development and international travel.
• A challenging and rewarding role within a growing pharmaceutical company in Vereeniging .