Pharmaceutical Regulatory Affairs Associate

Placements24; Willows (CA); Presencial; USD 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental, and vision insurance

Paid vacation and holidays

Professional development opportunities

Descripción de la vacante

Placements24 is seeking a diligent Pharmaceutical Regulatory Affairs Associate to support compliance initiatives for a client. Based in Welkom, the role focuses on preparing and submitting regulatory documents, maintaining filings, and staying updated on evolving regulatory landscapes.

The ideal candidate has 1–3 years of experience in regulatory affairs, strong attention to detail, and excellent communication skills to collaborate with R&D, Manufacturing and Marketing teams.

Formación

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• 1–3 years in pharmaceutical regulatory affairs or similar.
• Familiar with global regulatory submissions (ICH, FDA, EMA).
• Strong understanding of drug development and manufacturing principles.
• Excellent written and verbal communication; detail-oriented.
• Ability to manage multiple tasks and meet deadlines.

Responsabilidades

• Assist in preparation, review, and submission of regulatory dossiers (CTD, IND, NDA).
• Maintain regulatory databases and ensure accuracy of product registrations.
• Monitor and interpret changes in regulatory requirements and guidelines.
• Liaise with regulatory agencies to respond to queries and facilitate approvals.
• Review labeling, promotional materials, and advertising for regulatory compliance.
• Collaborate with internal teams (R&D, Manufacturing, Marketing) to meet regulatory requirements.

Conocimientos

Detail-oriented

Analytical skills

Excellent written/verbal communication

Educación

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Descripción del empleo

About the Role

Our client is seeking a diligent and organized Pharmaceutical Regulatory Affairs Associate to support their compliance initiatives in Welkom . This role is crucial for ensuring that pharmaceutical products meet all local and international regulatory standards throughout their lifecycle. You will assist in the preparation and submission of regulatory documents, maintain regulatory filings, and stay updated on evolving regulatory landscapes. The ideal candidate is detail-oriented, possesses excellent analytical skills, and thrives in a dynamic regulatory environment, contributing to the successful market access of vital medicines.

Key Responsibilities

• Assist in the preparation, review, and submission of regulatory dossiers (e.g., CTD, IND, NDA).
• Maintain regulatory databases and ensure the accuracy of product registration information.
• Monitor and interpret changes in regulatory requirements and guidelines impacting the company's products.
• Liaise with regulatory agencies as needed to respond to queries and facilitate approvals.
• Support the review of labeling, promotional materials, and advertising for regulatory compliance.
• Collaborate with internal teams (e.g., R&D, Manufacturing, Marketing) to ensure regulatory requirements are met.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 1-3 years of experience in pharmaceutical regulatory affairs or a closely related field.
• Familiarity with global regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA).
• Strong understanding of the drug development process and pharmaceutical manufacturing principles.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance plans.
• Paid vacation, sick leave, and public holidays.
• Professional development opportunities and training in regulatory affairs.
• A collaborative work environment with exposure to diverse regulatory challenges.