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SM of Regulatory Affairs CMC, biologics, is responsible for developing and implementing CMC regulatory strategies for all assigned products with the intention of achieving successful registration and life cycle management.
Responsibilities
Deliver regulatory CMC strategic leadership to support development and regulatory approval of multiple innovative products, mainly biologics, 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 or BLAs 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
Job Requirements
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/BLAs, post-approval life cycle management for biologics 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
Qualifications we seek in you!
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 with at least 5 years of experience managing biologics products
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
Intellectt INC
