Senior Regulatory Affairs Leader, Remote Pharma

Placements24; Graafwater; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Health insurance

Home office stipend

Flexible hours

Career growth

Leadership development

Résumé du poste

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist for a fully remote role. You will guide regulatory strategy and ensure lifecycle compliance for pharmaceutical products, preparing dossiers for authorities worldwide, including FDA, EMA, and SAHPRA.

You will lead cross-functional teams, monitor evolving guidelines, and oversee post-approval activities while working from a remote setting with global teams.

Qualifications

• Bachelor's or Master's degree in a scientific discipline with regulatory focus.
• Minimum 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience preparing and submitting dossiers to major health authorities.
• Deep knowledge of ICH guidelines and CTD formats.
• Ability to lead regulatory strategy in a global, remote setting.

Responsabilités

• Develop global regulatory strategies for NDAs, MAAs, and variations.
• Prepare and review regulatory submission documents (CTD modules, eCTD).
• Liaise with agencies, respond to queries, manage submissions.
• Provide regulatory guidance to R&D, clinical, manufacturing, and marketing.
• Monitor guidelines and advise on impacts and actions.
• Oversee post-approval activities: reports, supplements, labeling updates.
• Conduct regulatory intelligence to identify trends.
• Maintain regulatory filings and databases.
• Support regulatory inspections and audits.
• Assess regulatory impact of changes in products and processes.

Connaissances

Regulatory strategy

Dossier submissions

ICH guidelines

Cross-functional collaboration

Remote work

Formation

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related discipline

Master's degree preferred

Outils

RIMS

Submission gateways

Description du poste

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist for a fully remote role. You will guide regulatory strategy and ensure lifecycle compliance for pharmaceutical products, preparing dossiers for authorities worldwide, including FDA, EMA, and SAHPRA.

You will lead cross-functional teams, monitor evolving guidelines, and oversee post-approval activities while working from a remote setting with global teams.