Regulatory Affairs Specialist - Pharmaceutical Compliance

Placements24; George; Hybrid; ZAR 700,000 - 1,100,000; Full time

Benefits offered by this job

Competitive salary

Performance bonus

Health insurance

Retirement plan

Hybrid work model

Professional development

Job summary

Placements24 is seeking an experienced Regulatory Affairs Specialist to join our client’s team in George, Western Cape. You will prepare and submit regulatory filings, liaise with SAHPRA and other authorities, and drive lifecycle management for pharmaceutical products.

You will interpret evolving regulatory guidelines, collaborate with R&D, QA, and manufacturing, and implement strategic plans for product launches and market entries, ensuring compliance and product safety.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related field.
• Master's degree preferred.
• Minimum 4 years in pharmaceutical regulatory affairs.
• Strong knowledge of SAHPRA, FDA, EMA requirements.
• Proven experience preparing/regulatory filings.
• Excellent communication and project management skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) to authorities.
• Interpret regulations and apply to product development and manufacturing.
• Manage product registrations and lifecycle activities (variations, renewals).
• Liaise with regulatory agencies and respond to queries.
• Develop regulatory strategies for launches and market expansion.
• Monitor regulatory changes and assess impact on operations.

Skills

Regulatory affairs

Documentation

Stakeholder liaison

Regulatory strategy

Education

Bachelor's in Pharmacy/ Chemistry/ Biotechnology

Master's degree preferable

Tools

Regulatory information systems

Job description

About the Role

Our client, a significant player in the pharmaceutical sector, is actively seeking an experienced Regulatory Affairs Specialist to join their dedicated team in George, Western Cape . This role is crucial for ensuring that all our client's products meet the stringent regulatory requirements set forth by national and international health authorities. The specialist will be responsible for preparing and submitting regulatory documentation, liaising with regulatory bodies, and staying abreast of evolving legislative landscapes. This is an exciting opportunity to contribute to the successful market entry and lifecycle management of vital pharmaceutical products. The position requires a meticulous individual with a strong understanding of regulatory frameworks and a passion for ensuring product safety and efficacy. You will play a key role in maintaining our client's strong reputation for quality and compliance within the pharmaceutical industry in the George, Western Cape region.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to relevant health authorities.
• Interpret and apply regulatory guidelines and regulations to product development and manufacturing processes.
• Manage product registration and lifecycle maintenance activities, including variations and renewals.
• Liaise effectively with regulatory agencies, responding to queries and facilitating approvals.
• Develop and implement regulatory strategies for new product launches and market expansions.
• Monitor changes in the regulatory environment and assess their impact on the company's operations and products.
• Ensure internal compliance with relevant regulations and internal SOPs.
• Collaborate with R&D, manufacturing, quality assurance, and marketing departments to provide regulatory guidance.
• Maintain up-to-date regulatory databases and documentation systems.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• A Master's degree is preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of South African and international regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Proven experience in preparing and submitting regulatory filings.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Excellent analytical, organizational, and problem-solving skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Proficiency in regulatory information management systems.

Benefits

Our client is committed to fostering a supportive and rewarding work environment.

• competitive annual salary
• an attractive performance bonus structure
• comprehensive health insurance coverage
• retirement savings plan
• We offer a flexible working arrangement with a hybrid model, providing a balance between in-office collaboration and remote work flexibility.
• Professional development is strongly encouraged, with opportunities for training, workshops, and attendance at industry conferences.
• Employees benefit from a dynamic team culture and the chance to work on a diverse portfolio of pharmaceutical products.
• The location in George, Western Cape offers a beautiful environment to work and live in.