Senior Regulatory Affairs Specialist - CMC

Placements24; Queenstown; Sur place; NZD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Bonus potential

Medical,dental,vision insurance

Retirement savings plan

Paid time off & holidays

Professional development

Résumé du poste

Placements24 is seeking a Senior Regulatory Affairs Specialist with a CMC focus to lead the preparation and submission of CMC documentation for NDAs, MAAs, and variations. The role requires interaction with R&D, manufacturing, and QA teams to ensure regulatory compliance across multiple markets.

The ideal candidate has 6+ years in regulatory affairs with strong knowledge of FDA, EMA, ICH guidelines, and CTD Module 3.

Qualifications

• Bachelor's or higher in a relevant scientific field.
• Minimum 6 years in regulatory affairs with CMC focus.
• Experience preparing CMC sections (CTD Module 3).
• Knowledge of global CMC guidelines (FDA/EMA/ICH).
• Strong writing and communication skills; able to work cross-functionally.

Responsabilités

• Prepare, review, and submit CMC regulatory dossiers (NDAs/MAAs).
• Interpret global regulatory guidelines for CMC of drugs and biologics.
• Collaborate with R&D, manufacturing, QA to gather data and ensure compliance.
• Provide regulatory guidance on product development, manufacturing, and testing.
• Respond to agency queries and maintain regulatory documentation.
• Stay updated on evolving CMC regulations and SOPs.

Connaissances

Regulatory affairs

CMC submissions

FDA/EMA guidelines

ICH guidelines

CTD Module 3

Regulatory documentation

Regulatory strategy

communication

Formation

Bachelor degree in Chemistry/Pharmacy/related field

Master's degree (preferred)

Outils

Regulatory information systems

Description du poste

Our client, a leading biopharmaceutical company dedicated to developing innovative therapies, is seeking a highly experienced Senior Regulatory Affairs Specialist with a specialization in Chemistry, Manufacturing, and Controls (CMC). This vital role involves ensuring that our manufacturing processes and product quality meet the rigorous standards set by global health authorities. Based in Queenstown, Eastern Cape , this is an office-based position essential for direct engagement with our manufacturing and quality teams. The Senior RA Specialist will be responsible for the preparation and submission of CMC documentation for new drug applications, variations, and annual reports, playing a key part in bringing essential medicines to patients worldwide. This is an exceptional opportunity to contribute to impactful drug development in a collaborative and scientifically driven environment.

Key Responsibilities

• Prepare, review, and submit comprehensive CMC regulatory dossiers for new drug applications (NDAs, MAAs), variations, and annual reports in various global markets.
• Interpret and apply global regulatory guidelines (FDA, EMA, ICH, etc.) related to CMC requirements for drug substances and drug products.
• Collaborate closely with R&D, manufacturing, quality control, and quality assurance departments to gather necessary information and ensure regulatory compliance.
• Provide strategic regulatory guidance on CMC aspects of product development, including formulation, manufacturing process, and analytical testing.
• Assess the regulatory impact of proposed changes to manufacturing processes, specifications, or analytical methods.
• Respond to queries from regulatory agencies regarding CMC submissions in a timely and effective manner.
• Maintain regulatory documentation and ensure its accuracy and completeness.
• Stay abreast of evolving CMC regulatory landscape and advise the company on potential impacts and strategies.
• Contribute to the development and implementation of departmental SOPs and processes related to regulatory affairs.
• Participate in regulatory agency meetings and interactions concerning CMC issues.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific field. A Master's degree is preferred.
• A minimum of 6 years of experience in regulatory affairs, with a strong focus on CMC submissions for pharmaceuticals or biologics.
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g., FDA, EMA, ICH Q series).
• Proven experience in preparing and submitting CMC sections of regulatory dossiers (e.g., CTD Module 3).
• Strong understanding of pharmaceutical manufacturing processes, analytical methods, and stability testing.
• Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly.
• Strong organizational skills and meticulous attention to detail.
• Ability to work independently, manage multiple projects, and meet strict deadlines.
• Proficiency in regulatory information management systems is advantageous.
• Experience in interacting with regulatory agencies is highly desirable.
• Ability to work effectively in an office-based team environment.

Benefits

• Competitive salary and performance-based bonus.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan.
• Generous paid time off and public holidays.
• Opportunities for professional development and industry training.
• A stimulating work environment with a focus on innovation and patient well-being.
• Contribution to bringing life-saving therapies to market.