Regulatory Affairs Specialist

Placements24; Netherlands; Hybrid; EUR 80,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Vacation leave

Hybrid work model

Job summary

Placements24 is seeking an experienced Regulatory Affairs Specialist to join our client’s team in Welkom. You will manage regulatory submissions, advise on compliance, and coordinate with health authorities to support market approvals and ongoing compliance.

With 4+ years in pharmaceutical regulatory affairs and a background in Pharmacy, Life Sciences, or Law, you will navigate international guidelines (FDA, EMA, SAHPRA), review labeling and advertising, and guide product lifecycle activities in

Qualifications

• Bachelor's or Master's degree in Pharmacy, Law, Life Sciences, or related field.
• Minimum of 4 years in pharmaceutical regulatory affairs.
• Experience in preparing and submitting regulatory dossiers.
• Strong knowledge of international frameworks (FDA, EMA, SAHPRA).
• Excellent written and verbal communication, negotiation, and influencing skills.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Prepare, review, and submit regulatory submissions to authorities.
• Interpret and advise on regulatory requirements impacting development, manufacturing, and marketing.
• Liaise with regulatory agencies, respond to queries, manage approvals.
• Ensure labeling, promotional materials, and advertising comply with regulations.
• Maintain regulatory intelligence and track changes in legislation.
• Support post-market surveillance and lifecycle regulatory activities.

Skills

Regulatory affairs

Dossier submissions

Cross-functional collaboration

Regulatory guidance

Education

Bachelor's or Master's in Pharmacy/Life Sciences/Law

Job description

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to join their dynamic team based in Welkom. This pivotal role involves ensuring that all pharmaceutical products meet the complex and evolving regulatory requirements for market approval and continued compliance. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance across the organization. This hybrid position offers the flexibility to work remotely for a portion of the week while maintaining essential on-site collaboration with key departments.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to national and international health authorities.
• Interpret and advise on regulatory requirements and guidelines impacting product development, manufacturing, and marketing.
• Liaise directly with regulatory agencies, respond to queries, and manage the approval process.
• Ensure that all product labeling, promotional materials, and advertising comply with applicable regulations.
• Maintain regulatory intelligence, tracking changes in legislation and assessing their impact on the company's products and strategies.
• Support post-market surveillance activities and manage product lifecycle regulatory activities.

Requirements

• Bachelor's or Master's degree in Pharmacy, Law, Life Sciences, or a related discipline.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting various types of regulatory dossiers.
• Thorough understanding of international regulatory frameworks and guidelines (e.g., FDA, EMA, SAHPRA).
• Excellent written and verbal communication skills, including strong negotiation and influencing abilities.
• Ability to manage multiple projects simultaneously in a fast-paced environment.

Benefits

• Competitive annual salary package with performance incentives.
• Comprehensive health, dental, and vision insurance.
• Retirement fund participation.
• Generous leave policy for vacation and personal time.
• A hybrid work model promoting work-life integration and effective collaboration.