Regulatory Affairs Manager

Placements24; Klerksdorp; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Executive-level salary

Remote-first role

Professional development opportunities

Job summary

Placements24, a respected pharmaceutical entity, seeks a seasoned Regulatory Affairs Manager for a fully remote role. You will navigate global regulatory landscapes, shape submission strategies, and ensure compliance across markets while coordinating with R&D, manufacturing, and commercial teams.

This role demands a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, and a proven track record of successful submissions (SAHPRA, FDA, EMA).

Qualifications

• 7+ years of progressive regulatory affairs experience.
• Proven track record of successful submissions and approvals in major markets (SAHPRA, FDA, EMA).
• In-depth knowledge of ICH and global submission requirements.
• Strong communication and negotiation skills.
• Ability to work independently in a remote setting.

Responsibilities

• Develop and execute regulatory strategies for product registrations and lifecycle management.
• Prepare and submit regulatory dossiers (e.g., CTD) to health authorities in various regions.
• Interpret and communicate regulatory requirements to stakeholders.
• Act as the liaison with regulatory agencies for submissions.
• Review promotional materials for regulatory compliance.
• Manage post-approval changes and product registrations.
• conducts regulatory intelligence to stay updated on legislation.
• Collaborate with R&D, manufacturing and commercial teams.

Skills

Regulatory strategy

CTD submissions

Regulatory intelligence

Cross-functional coordination

Regulatory compliance

Education

Master's or PhD in Pharmaceutical Science

Tools

Regulatory information systems

CTD format

Job description

About the Role

Our client, a distinguished pharmaceutical entity, is actively recruiting for a highly experienced Regulatory Affairs Manager to operate in a fully remote capacity. This pivotal role is central to ensuring our pharmaceutical products meet all requisite regulatory standards across various global markets. As a remote-first position, you will leverage your expertise to navigate complex regulatory landscapes, develop submission strategies, and maintain compliance without the need for physical office presence. You will work closely with internal teams, including R&D, manufacturing, and commercial, as well as external regulatory bodies. This is an exceptional opportunity for a seasoned regulatory professional seeking a challenging and rewarding career from the convenience of their home office, contributing significantly to the successful launch and lifecycle management of innovative medicines.

Key Responsibilities

• Develop and execute regulatory strategies for product registration and lifecycle management.
• Prepare and submit regulatory dossiers (e.g., CTD) to health authorities in various regions.
• Interpret and communicate regulatory requirements, guidelines, and trends to relevant stakeholders.
• Act as the primary liaison with regulatory agencies for all submission-related activities.
• Review and approve promotional materials, labeling, and packaging to ensure regulatory compliance.
• Manage post-approval changes and maintain product registrations.
• Conduct regulatory intelligence activities to stay informed of evolving legislation.
• Collaborate with cross-functional teams to address regulatory queries and challenges.
• Oversee the regulatory compliance of existing products.
• Contribute to the strategic planning and decision-making processes related to regulatory affairs.

Requirements

• Master's or Ph.D. degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of regulatory guidelines, ICH, and global submission requirements.
• Strong strategic thinking, analytical, and problem-solving skills.
• Excellent written and verbal communication and negotiation skills.
• Demonstrated ability to manage complex projects and work independently in a remote setting.
• Proficiency with regulatory information management systems and CTD format.
• Experience in liaising directly with health authorities.
• Must be comfortable working in a fully remote environment with reliable internet connectivity.

Benefits

Our client offers a highly competitive executive-level salary and a comprehensive benefits package. As a remote employee, you gain unparalleled flexibility and autonomy, eliminating commute stress and allowing for a superior work-life integration. You will be instrumental in shaping the regulatory pathway for groundbreaking pharmaceutical products. Opportunities for continuous professional development, including attendance at international regulatory affairs conferences, are provided. The company fosters a culture of innovation and collaboration, offering a stimulating work environment and significant career advancement potential.