Remote Regulatory Affairs Specialist

Placements24; Waukee (IA); Hybrid; USD 90.000 - 135.000; Vollzeit

Benefits dieser Stelle

Bonuses

Medical coverage

Retirement plan

Remote work

Professional development

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory Affairs

Pharmaceutical

Documentation

Communication

Ausbildung

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Jobbeschreibung

About the Role

Our client is seeking a highly competent and strategic Remote Regulatory Affairs Specialist to join their dynamic team, supporting operations from anywhere within South Africa, ideally coordinating with their Paarl -based operations. This role is integral to ensuring that our client's pharmaceutical products meet all necessary regulatory requirements for approval and marketing in various global markets. You will manage regulatory submissions, liaise with health authorities, and provide expert guidance on regulatory strategies. This fully remote position is perfect for an experienced regulatory professional who thrives in an independent work environment and possesses a thorough understanding of international pharmaceutical regulations.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Interpret and apply relevant regulatory guidelines and legislation to product development and registration strategies.
• Serve as the primary point of contact for health authorities regarding regulatory submissions and inquiries.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Collaborate with R&D, quality assurance, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Maintain regulatory documentation and databases, ensuring all records are accurate and up-to-date.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum of 5 years of progressive experience in Pharmaceutical Regulatory Affairs.
• Demonstrated experience in preparing and submitting marketing authorization applications in major markets (e.g., FDA, EMA, SAHPRA).
• Thorough knowledge of ICH guidelines, GxP requirements, and global regulatory submission processes.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with the ability to negotiate and influence effectively.

Benefits

• Competitive annual salary and performance-related bonuses.
• Comprehensive medical coverage and retirement benefits.
• Flexible working hours and the freedom to work remotely.
• Professional development opportunities, including regulatory affairs training and certifications.
• A collaborative and supportive team environment, fostering continuous learning and career progression.