What are the responsibilities and job description for the Regulatory Affairs Specialist CMC position at Jobleads-US?
Company Overview:
We are a global healthcare leader dedicated to discovering and delivering life-changing medicines. Our employees work together to improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Job Description:
This Principal Scientist- Global Regulatory Affairs-CMC role is responsible for providing strategic direction to expedite CMC development of Lilly's portfolio and technical agenda. The successful candidate will have a strong working knowledge of global regulations and guidelines, as well as a strong technical knowledge of CMC development and manufacturing processes.
Key Responsibilities:
* Oversee the preparation and documentation of specified regulatory submissions* Provide regulatory leadership and direction for products listed as primary responsibilities* Develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS, manufacturing, quality control and quality assurance* Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
Requirements:
* Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline)* Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function* Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered* Knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing;* Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
We are a global healthcare leader dedicated to discovering and delivering life-changing medicines. Our employees work together to improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Job Description:
This Principal Scientist- Global Regulatory Affairs-CMC role is responsible for providing strategic direction to expedite CMC development of Lilly's portfolio and technical agenda. The successful candidate will have a strong working knowledge of global regulations and guidelines, as well as a strong technical knowledge of CMC development and manufacturing processes.
Key Responsibilities:
* Oversee the preparation and documentation of specified regulatory submissions* Provide regulatory leadership and direction for products listed as primary responsibilities* Develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS, manufacturing, quality control and quality assurance* Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
Requirements:
* Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline)* Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function* Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered* Knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing;* Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
