Senior Regulatory Affairs Lead - Global Submissions

Placements24; Bloemfontein; Hybrid; ZAR 1.100.000 - 1.600.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Paid time off

Professional development

Wellness programs

Zusammenfassung

Placements24 is seeking a Senior Regulatory Affairs Specialist to manage global regulatory submissions from our Bloemfontein office. This role ensures timely approvals across markets by preparing, submitting, and maintaining dossiers and liaising with health authorities.

The ideal candidate has 5+ years in regulatory affairs in the pharmaceutical industry, with strong knowledge of ICH guidelines and experience coordinating cross-functional teams to support product development and lifecycle

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Minimum 5 years' experience in regulatory affairs in pharma.
• Proven experience preparing and submitting global dossiers.

Aufgaben

• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, MAA) for global markets.
• Manage lifecycle submissions, including amendments, variations, and annual reports.
• Serve as the primary point of contact with health authorities in various regions.
• Interpret and communicate regulatory requirements to internal stakeholders, including R&D, manufacturing, and marketing.
• Develop and implement regulatory strategies to support product development and commercialization.
• Ensure all regulatory submissions are accurate, complete, and compliant with relevant guidelines.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with cross-functional teams to resolve regulatory issues and facilitate product approvals.
• Maintain regulatory documentation and databases.
• Contribute to the development and implementation of regulatory affairs policies and procedures.

Kenntnisse

5+ years regulatory experience

Regulatory affairs

Global regulatory submissions

Project management

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree or equivalent experience preferred

Tools

Regulatory information management systems (RIMS)

Jobbeschreibung

Placements24 is seeking a Senior Regulatory Affairs Specialist to manage global regulatory submissions from our Bloemfontein office. This role ensures timely approvals across markets by preparing, submitting, and maintaining dossiers and liaising with health authorities.

The ideal candidate has 5+ years in regulatory affairs in the pharmaceutical industry, with strong knowledge of ICH guidelines and experience coordinating cross-functional teams to support product development and lifecycle