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Walker Cole International are currently searching for a Senior Regulatory CMC Specialist to join an exciting global consumer healthcare business with a portfolio of household name brands. This is an opportunity for somebody with mentoring experience or project & people management to progress their career. Based in Southeast England.
Your responsibilities as a Senior Regulatory CMC Specialist:
- Oversee the authoring and reviewing of CMC documents, coordination and management of global submissions.
- Act as global/regional CMC representative within cross-functional team projects.
- Lead the preparation of CMC information for submission to global regulatory agencies.
- Line management.
As a Senior Regulatory CMC Specialist, you will have:
- Expertise in Regulatory CMC strategy and authoring, module III.
- Knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
- Knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage.
- Mentoring or line management experience.
CMC // Regulatory // Senior Specialist // Post approval // Senior Regulatory CMC Specialist // Regulatory CMC // Module 3 // OTC // Consumer Healthcare
Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
ScienceIndustries
Consumer Services, Pharmaceutical Manufacturing, and Retail Pharmacies
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#J-18808-LjbffrSenior Regulatory CMC Specialist in Reading employer: Walker Cole International
Walker Cole International is an exceptional employer that prioritises a dynamic and patient-focused work culture, making it an ideal place for professionals in Regulatory Affairs. With a commitment to employee growth and development, the company offers unique opportunities to engage with international markets while ensuring compliance and driving product lifecycle management. Located in a vibrant industry hub, employees benefit from collaborative teamwork and the chance to make a meaningful impact in the pharmaceutical sector.
