Remote Regulatory Affairs Specialist - Global Markets

Placements24; Waukee (IA); Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Bonuses

Medical coverage

Retirement plan

Remote work

Professional development

Job summary

Placements24 is seeking a highly competent Remote Regulatory Affairs Specialist to support global pharmaceutical operations from anywhere, coordinating with Paarl-based teams where needed.

You will manage regulatory submissions (CTD/ANDA/NDA), interpret guidelines, and advise on strategies to ensure compliance across markets throughout the product lifecycle.

The role requires 5+ years in regulatory affairs, a relevant science degree, and demonstrated excellence in written and verbal communication.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum 5 years in Pharmaceutical Regulatory Affairs.
• Experience submitting MAAs in major markets (FDA, EMA, SAHPRA).
• Knowledge of ICH, GxP, and global submission processes.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) to health authorities.
• Interpret regulatory guidelines and apply them to product development and registration strategies.
• Act as primary contact for health authorities regarding submissions and inquiries.
• Monitor regulatory changes and assess impact on products and operations.
• Collaborate with R&D, QA, and commercial teams to ensure lifecycle compliance.
• Maintain regulatory documentation and databases with accuracy.

Skills

Regulatory Affairs

Pharmaceutical

Documentation

Communication

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Job description

Placements24 is seeking a highly competent Remote Regulatory Affairs Specialist to support global pharmaceutical operations from anywhere, coordinating with Paarl-based teams where needed.

You will manage regulatory submissions (CTD/ANDA/NDA), interpret guidelines, and advise on strategies to ensure compliance across markets throughout the product lifecycle.

The role requires 5+ years in regulatory affairs, a relevant science degree, and demonstrated excellence in written and verbal communication.