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This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior CMC Regulatory Affairs Professional. In this role, you will play a crucial part in the clinical development process, focusing on CMC regulatory submissions, compliance, and stakeholder management. Your expertise will directly contribute to improving global health outcomes by ensuring that therapeutic innovations meet regulatory standards efficiently. This position offers the opportunity to work within a collaborative team environment, driving impactful changes in the biotechnology and pharmaceutical fields. Join us in making a difference by shaping regulatory strategies that benefit patients worldwide.
Accountabilities
- Conduct and deliver high-quality, on-time CMC regulatory activities.
- Author administrative and CMC regulatory documents and collaborate with project SMEs.
- Manage full CMC submissions, including planning and compilation of submission packages.
- Coordinate submission activities and ensure compliance with regulatory requirements.
- Act as the main GRA point of contact for LRAs and stakeholders.
- Demonstrate excellent communication and stakeholder management skills.
- Utilize strong organizational and time management abilities.
Requirements
- University degree in biological sciences or related health sciences.
- Minimum of 5 years’ experience in the biotech or pharmaceutical industry, specifically in CMC regulatory affairs.
- Strong technical regulatory expertise with knowledge of the regulatory framework in multiple key regions.
- Proficient in CMC writing skills and evaluating scientific information for accuracy.
- Knowledge of Good Manufacturing Practices is highly regarded.
Benefits
- Opportunity for growth and impact within a collaborative team.
- Chance to contribute to significant medical advancements.
- Flexible work environment with remote working options.
- Engagement with a forward-thinking and innovative team.
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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