Key responsibilities CMC Regulatory Strategy and Change Management Manufacturing and Testing Practice (MTP) Establishment CMC Technical Assessment and Regulatory Support Submission and Approval of Marketed Product Maintenance Regulatory Compliance and System Regulatory Policy Influence and Advocacy Cross Function/Department
Job Description Responsibilities Lead Regulatory CMC Policy & Intelligence efforts to effectively navigate the regulatory landscape, advocate for CMC policies, and contribute to achieving strategic policy objectives. Develop and implement CMC policy strategies that align with regulatory requirements and
The role holder is responsible for providing expert technical support to commercial products manufactured internally at AZ sites and externally at contract facilities. This job description is relevant for on-market technical leaders whose subject matter expertise
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
Unit Description: DNV - Area North China is part of the Maritime Region Greater China and consists of around 150 employees in 5 major locations. Services delivered are related to ship classification of vessels and offshore
DNV-Area China South is part of the Maritime Region Greater China and consists of more than 100 employees in 4 major locations. Services delivered are related to ship classification of vessels and offshore units as well
Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible
Work ScheduleStandard (Mon-Fri) Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Company Information About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of
JOB DESCRIPTION: RESPONSIBILITIES: Set up regulatory strategy, product registration timeline and ensure well implement. Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Work ScheduleStandard (Mon-Fri) Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Office, Some degree of PPE (Personal Protective Equipment)
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Join Us as a Senior Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than