With the following requirements:
• University Degree in Life sciences or an equivalent field
• Strong experience in Regulatory Affairs preferably in a global Food & Beverage or Pharmaceutical/Biotech company with deep experience in product lifecycle and technical expertise in CMC matters
• Proven success in communicating and influencing global teams on matters of CMC strategy for commercial and development programs
• Substantial Regulatory planning and submission experience across multiple Authorities
• Ability to build effective project teams and foster a strong collaborative culture internally and with suppliers
• Strong problem solving and organizational capabilities coupled with proven leadership skills
• Demonstrated ability to communicate, present and influence credibly and effectively at all levels of the organization
• Strong reputation in engaging in proactive behavior and seizing opportunities
• Fluent English is a must
As a Director CMC Governance, you will be responsible for overseeing all relevant regulatory CMC aspects from pre-clinical to manufacturing steps and leading registration.
Your specific responsibilities will be:
• Proactively manage CMC aspects of global commercial programs including overseeing preparation, delivery and maintenance of global CMC submissions
• Manage relevant CMC relationships with external partners to ensure unified CMC vision and execution for partnered programs
• Interpret relevant existing or new regulatory requirements, evaluate draft guidelines, write impact assessments, leads gap analysis and propose solution and strategies to remediate risks. Manage and ensure compliance with all reporting requirements, including annual and periodic reports
• Deliver quality products and processes with appropriate validation and regulatory documentation for submission, and within agreed timelines and budget
• Provide options and innovative solution to drive the project ahead
• Serve as the interface between the R&D Global Team and the Global Manufacturing team
• Lead a multi-disciplinary team in a complex environment to establish CMC strategies for commercial products, late and early stage development programs
• Lead efforts to prepare data packages to support post-approval CMC changes. Serve as Subject Matter Expert during interactions with regulatory authorities and at meetings with business partners
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