Senior Pharmaceutical Regulatory Affairs Manager

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Provident fund

Performance bonuses

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Manager for our Port Elizabeth, Eastern Cape client. The role leads regulatory strategy, submissions, and lifecycle management across SAHPRA, FDA, and EMA.

A strong leadership track record and expert knowledge of global regulations are required. The position offers hybrid work with office presence in Port Elizabeth and flexible remote options, along with a competitive benefits package and career development opportunities in a

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry or related field; Master’s preferred.
• 7+ years in pharmaceutical regulatory affairs with leadership experience.
• Strong knowledge of SAHPRA, FDA and EMA submission requirements.
• Proven track record in obtaining product registrations and approvals.

Responsibilities

• Develop and execute regulatory strategies for new and existing products.
• Prepare and submit CTD dossiers to SAHPRA, FDA and EMA.
• Engage with regulatory authorities to resolve queries and enable approvals.
• Manage post-approval activities including renewals and variations.
• Provide regulatory guidance to R&D, manufacturing, and marketing teams.
• Lead and mentor the regulatory affairs team.

Skills

Regulatory leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Project management

GCP/GMP/GVP knowledge

Education

Bachelor’s degree in Pharmacy or Life Sciences

Master’s degree preferred

Job description

Our client, a leading pharmaceutical company, is seeking an accomplished Senior Pharmaceutical Regulatory Affairs Manager to join their team in Port Elizabeth, Eastern Cape. This crucial role involves overseeing the regulatory strategy and execution for pharmaceutical products, ensuring compliance with all applicable national and international regulations. The ideal candidate will possess a deep understanding of regulatory frameworks, a strong track record in managing regulatory submissions, and excellent leadership capabilities. This hybrid position allows for both collaborative work within our Port Elizabeth office and remote flexibility, supporting a dynamic and efficient approach to regulatory affairs.

Key Responsibilities

• Develop and implement regulatory strategies for new and existing pharmaceutical products in alignment with company objectives and market opportunities.
• Manage the preparation, compilation, and submission of regulatory dossiers (e.g., CTD) to health authorities, including SAHPRA, FDA, and EMA.
• Liaise directly with regulatory agencies to address queries, negotiate requirements, and facilitate the approval process for drug products.
• Ensure ongoing compliance of marketed products by managing post-approval changes, renewals, and annual reporting requirements.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Provide regulatory guidance and support to internal departments, including R&D, clinical affairs, manufacturing, and marketing.
• Lead and mentor a team of regulatory affairs professionals, fostering their development and ensuring high-quality output.
• Conduct regulatory intelligence activities to identify emerging trends and inform strategic decision-making.
• Review promotional materials and product labeling for regulatory compliance.
• Oversee the regulatory aspects of product lifecycle management, from development through post-marketing surveillance, within the Port Elizabeth context.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; Master's degree or equivalent preferred.
• A minimum of 7 years of experience in pharmaceutical regulatory affairs, with a significant portion in a managerial or leadership capacity.
• Comprehensive knowledge of pharmaceutical regulations, guidelines, and submission requirements in key markets (South Africa, US, Europe).
• Proven experience in managing regulatory submissions for various product types (e.g., generics, new chemical entities).
• Demonstrated success in obtaining product registrations and approvals.
• Excellent communication, negotiation, and interpersonal skills.
• Strong project management abilities and experience managing multiple priorities.
• Ability to work effectively in a fast-paced, cross-functional team environment.
• Familiarity with Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Pharmacovigilance Practices (GVP).
• Experience with regulatory affairs software and databases is beneficial for our Port Elizabeth based operations.

Benefits

• Our client offers a competitive salary, executive-level benefits package including comprehensive medical aid, provident fund, and performance-related bonuses. This hybrid role provides professional growth opportunities within a respected pharmaceutical organization located in Port Elizabeth, Eastern Cape. We foster a culture of continuous learning and provide support for professional development. Join us in shaping the regulatory future of pharmaceuticals.