Senior Regulatory Affairs Specialist

Placements24; Pretoria; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Global regulatory exposure

Professional development

Supportive regulatory team in Pretoria

Job summary

Placements24 in Pretoria is seeking a seasoned Senior Regulatory Affairs Specialist to join our dedicated team. You will manage regulatory dossiers and oversee submissions to health authorities, ensuring global regulatory compliance.

You will collaborate with R&D, manufacturing, and legal to develop regulatory strategies and respond to queries during reviews. The role offers influence on product launches and lifecycle management and opportunities for professional growth in a dynamic

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field required.
• Minimum 6 years of regulatory affairs experience in the pharmaceutical industry.
• Demonstrated success in preparing and submitting regulatory dossiers to major health authorities.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities in various regions.
• Interpret and advise on complex regulatory requirements impacting product development and registration.
• Liaise with health authorities during reviews, responding to queries and facilitating approvals.
• Develop and implement regulatory strategies to support global product launches and lifecycle management.
• Monitor regulatory intelligence and communicate changes impacting products or operations.
• Collaborate with R&D, manufacturing, marketing, and legal to ensure compliance.

Skills

Regulatory submissions

Regulatory strategy

Health authority liaison

ICH/FDA/EMA knowledge

Project management

Regulatory compliance

Education

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

Advanced degree preferred

Job description

About the Role

Our client is seeking a seasoned Senior Regulatory Affairs Specialist to join their dedicated team in Pretoria . This role is crucial for ensuring that our pharmaceutical products achieve and maintain regulatory compliance in all target markets. You will be responsible for preparing, submitting, and managing regulatory dossiers, as well as staying ahead of evolving global regulatory requirements. The successful candidate will possess a strong understanding of pharmaceutical regulations and a keen eye for detail. This position offers a significant opportunity to influence regulatory strategies and contribute to the successful launch and lifecycle management of vital medicines, working closely with product development and commercial teams.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, variations, renewals) to health authorities in various regions.
• Interpret and advise on complex regulatory requirements and guidelines impacting product development and registration.
• Liaise with health authorities during the review process, responding to queries and facilitating approvals.
• Develop and implement regulatory strategies to support global product launches and lifecycle management.
• Monitor regulatory intelligence and communicate changes in regulations that may impact the company's products or operations.
• Collaborate with internal stakeholders, including R&D, manufacturing, marketing, and legal, to ensure regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry.
• Demonstrated success in preparing and submitting successful regulatory dossiers to major health authorities.
• Thorough understanding of international regulatory guidelines (e.g., ICH, FDA, EMA) and South African regulations.
• Excellent analytical, problem-solving, and project management skills.
• Strong written and verbal communication skills, with the ability to articulate complex regulatory positions effectively.

Benefits

• Competitive salary and benefits package.
• Opportunity to work on diverse and innovative pharmaceutical products.
• Exposure to global regulatory landscapes and challenges.
• Professional development programs and support for continuous learning.
• Key role within the regulatory team based in Pretoria .