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Responsibilities:

• Deliver regulatory CMC strategic leadership to support development and regulatory approval of multiple innovative products, mainly small molecules, for a wide variety of therapeutic areas and dosage forms.
• Lead project related regulatory CMC activities in a matrix structure
• Manage and implement planning, preparation, and submission of high-quality CMC related applications with a focus on the US and EU/EMEA regions
• Ensure that CMC-related applications and/or sections, including IMPDs/INDs, investigator brochures, scientific advice requests, agency briefing documents, and MAAs are complete, well written, and meet all relevant requirements
• In collaboration with the Regulatory Strategy Leads, coordinate negotiations on CMC topics with regulatory agencies to resolve CMC issues
• Effectively communicate regulatory CMC strategy to Regulatory Strategy leads and other internal stakeholders
• Drive adherence to CMC regulatory guidelines relevant for the development of biologics
• Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
• Assess the impact of new regulations, guidance and directives and advise the regulatory organization on requirements to maintain compliance with regulatory operations activities.
• Manage post approval changes where needed

• Prior experience and a successful track record within the biotechnology and/or pharmaceutical industry in successful preparation and submission of IMPDs/INDs, Scientific Advice, MAAs, post-approval life cycle management for mainly small molecule products. Experience with medical device and combination products would be advantageous.
• Strong knowledge of current Good Manufacturing Practices (GMP), drug (and biologics) development regulations and guidelines including ICH, EMA and FDA guidelines
• Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication

• This position requires a self-motivated and organized individual with the ability to exercise flexibility, and solution focused decision making. The successful candidate should be self-motivated and well organized.
• Master's degree in life sciences in biochemistry, chemistry, biology, or related pharmaceutical fields; higher degree, such as a PhD is desirable.
• At least 12 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in the regulatory CMC area (mainly dealing with small molecules)
• Prior experience in big (or mid-size) Pharma companies
• Proven project management delivery
• Robust communication and presentation skills
• Proven track record in working cross-culturally