Senior Regulatory Affairs Specialist - CMC

Placements24; Lorenziberg; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Zusammenfassung

Placements24 is seeking a Senior Regulatory Affairs Specialist specialized in CMC to lead global regulatory submissions and ensure compliance across NDAs, MAAs, variations, and annual reports. The role requires coordinating with R&D, manufacturing, QC and QA, interpreting FDA/EMA/ICH guidelines and CTD Module 3, and developing regulatory strategies to accelerate access to medicines.

Office-based in Austria with collaboration across manufacturing teams; strong communication and project management

Qualifikationen

• Bachelor's degree in Chemistry, Pharmacy, or related field; Master's preferred.
• 6+ years in regulatory affairs with a focus on CMC for pharma/biologics.
• Knowledge of FDA, EMA, ICH guidelines and CTD Module 3.
• Experience preparing and submitting CMC sections of dossiers.

Aufgaben

• Prepare, review, and submit CMC dossiers for NDAs/MAAs and variations.
• Interpret global CMC guidelines and advise on regulatory strategy.
• Collaborate with R&D, manufacturing, QC, and QA to collect data.
• Maintain regulatory documentation and respond to agency inquiries.
• Support SOP development and regulatory meetings.

Kenntnisse

CMC submissions

Regulatory affairs

Global guidelines

CTD Module 3

Analytical testing

Ausbildung

Bachelor's degree in Chemistry/Pharmacy

Master's degree preferred

Tools

Regulatory information systems

Jobbeschreibung

About the Role

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.