Senior Regulatory Affairs Specialist - Global Submissions

Placements24; Bloemfontein; Hybrid; ZAR 1,100,000 - 1,600,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Wellness programs

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

5+ years regulatory experience

Regulatory affairs

Global regulatory submissions

Project management

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree or equivalent experience preferred

Tools

Regulatory information management systems (RIMS)

Job description

About the Role Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist to manage global regulatory submissions from their **Bloemfontein** office. This vital role ensures that our client's innovative pharmaceutical products gain timely approval in markets worldwide. The Senior Regulatory Affairs Specialist will be responsible for preparing, submitting, and maintaining regulatory dossiers, liaising with health authorities, and staying abreast of evolving global regulatory landscapes. This is an excellent opportunity for a seasoned regulatory professional to contribute significantly to bringing new therapies to patients globally. The ideal candidate possesses a deep understanding of international regulatory requirements and exceptional organizational skills. We are committed to fostering professional development and scientific advancement within our **Bloemfontein** team. The **Bloemfontein** location provides a stable and supportive environment for this critical function, enabling effective contribution to global drug access.

Key Responsibilities

• 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.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; Master's degree or equivalent experience preferred.
• A minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting global regulatory dossiers.
• In-depth knowledge of international regulatory guidelines and submission requirements (e.g., ICH, FDA, EMA, PMDA).
• Familiarity with drug development processes and the pharmaceutical industry.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Strong organizational and project management skills.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in regulatory information management systems (RIMs) is a plus.
• Team player with strong interpersonal skills and the ability to collaborate effectively.

Benefits

• Our client offers a competitive salary package, performance bonuses, and a comprehensive benefits program, including health, dental, and vision insurance.
• We provide a retirement savings plan, generous paid time off, and paid holidays.
• Opportunities for continuous professional development, including attendance at key industry conferences and specialized training, are readily available.
• The **Bloemfontein** office provides a professional and supportive work setting, fostering collaboration and innovation.
• Employees also benefit from wellness programs and employee assistance services.

This role in **Bloemfontein** offers a significant opportunity to impact global healthcare by facilitating access to essential medicines. Join our dedicated team and contribute to a meaningful mission.