BioSpace, Inc.
Advisor - Global Regulatory Affairs CMC
BioSpace, Inc., Indianapolis, Indiana, us, 46262
Job Details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and registrations. As the Project Leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical and operational support for Clinical Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The Regulatory Scientist is expected to develop and implement innovative Regulatory Strategies to advance the development of assigned product(S).
Regulatory & Scientific Expertise
• Deep technical knowledge of manufacturing sciences and processes
• Recognized internally and externally for broad knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations
• Develops and evaluates global CMC regulatory strategies in collaboration with other regulatory, Manufacturing, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval
• Anticipates and resolves key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Provides consultation across global regulatory network to assess CMC regulatory strategies, and provide regulatory and technical expertise, to strengthen submission or minimize risk.
• Reviews and approves CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
• Takes on and independently manages risky (i.e., technically challenging, political) problems and identifies creative and/or alternative solutions that support GRA-CMC objectives and partner requirements.
Influence
• Makes technical decisions on CMC regulatory issues, setting new company direction and impacting product submissions across geographies.
• Advises CMC customers, central and regional regulatory support, and management on resolve complex issues.
• Recognized as model of strong leadership behaviors and provides mentoring to regulatory staff on technical and/or regulatory topics.
• Leads strategic initiatives to incorporate new regulations, guidance, and company positions into Lilly processes/guidelines, tools, and/or training materials, while building in efficiencies.
• Advises Technical Steering teams and network forums, for the development of complex regulatory strategies
• Exhibits strong leadership behaviors and is sought out as a functional mentor within Indianapolis site regulatory and
product support network.
• Influences policy and emerging regulations worldwide for CMC issues (internally and externally)
• Leads initiatives within industry organization(s), effectively increasing Lilly's visibility and influence of evolving regulatory positions.
Lead / Partner
• Leads communication strategy for affiliates and/or senior management, to manage submission requirements, mitigate risk, and maintain regulatory commitment compliance
• Monitors global regulatory news and provides interpretation and internal communication as appropriate
• Leads technical and regulatory review forums, to evaluate submission strategy and/or data acceptability. Develops complex global CMC regulatory strategies and networks for alignment across Manufacturing, Quality, GRA, product team(s) and affiliates, as required, to enable timely completion of product registration milestones.
• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, and response to question submissions.
• Effectively collaborates with Health Authority CMC reviewers at US FDA during scientific advice meetings or submission review and interacts with global Health Authorities, as required
• Attends and/or leads industry forums to increase Lilly's visibility
• Participates in forums that share regulatory information across GRA components
• Participates in the development of corporate positions on, and in response to, proposed agency regulations and guidelines.
Minimum Qualification Requirements:
. B.S. Degree in Chemistry, Pharmacy, Biology, Biochemistry, or related Science or Bachelor's with equivalent experience
. Pharmaceutical industry experience in a manufacturing environment, e.g., Manufacturing Sciences and Technology, Quality Assurance, Analytical Laboratories, or Manufacturing (7+ years)
. Prior regulatory CMC experience (minimum 3 years) or equivalent combination of technical and regulatory guidance knowledge
Other Information/Additional Preferences:
Synthetic Peptide/Protein experience preferred
Demonstrated knowledge of CMC regulatory guidance's
Demonstrated strong interpersonal and leadership skills; ability to interact effectively within group and with customer base
Demonstrated ability to organize and analyze detailed information
Demonstrated ability to identify, drive and support business process improvement initiatives
Demonstrated ability to work independently
Demonstrated strong written and verbal communication skills
Demonstrated ability to understand and apply risk analysis concepts
Demonstrated ability to deliver projects according to agree upon timelines
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and registrations. As the Project Leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical and operational support for Clinical Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The Regulatory Scientist is expected to develop and implement innovative Regulatory Strategies to advance the development of assigned product(S).
Regulatory & Scientific Expertise
• Deep technical knowledge of manufacturing sciences and processes
• Recognized internally and externally for broad knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations
• Develops and evaluates global CMC regulatory strategies in collaboration with other regulatory, Manufacturing, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval
• Anticipates and resolves key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Provides consultation across global regulatory network to assess CMC regulatory strategies, and provide regulatory and technical expertise, to strengthen submission or minimize risk.
• Reviews and approves CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
• Takes on and independently manages risky (i.e., technically challenging, political) problems and identifies creative and/or alternative solutions that support GRA-CMC objectives and partner requirements.
Influence
• Makes technical decisions on CMC regulatory issues, setting new company direction and impacting product submissions across geographies.
• Advises CMC customers, central and regional regulatory support, and management on resolve complex issues.
• Recognized as model of strong leadership behaviors and provides mentoring to regulatory staff on technical and/or regulatory topics.
• Leads strategic initiatives to incorporate new regulations, guidance, and company positions into Lilly processes/guidelines, tools, and/or training materials, while building in efficiencies.
• Advises Technical Steering teams and network forums, for the development of complex regulatory strategies
• Exhibits strong leadership behaviors and is sought out as a functional mentor within Indianapolis site regulatory and
product support network.
• Influences policy and emerging regulations worldwide for CMC issues (internally and externally)
• Leads initiatives within industry organization(s), effectively increasing Lilly's visibility and influence of evolving regulatory positions.
Lead / Partner
• Leads communication strategy for affiliates and/or senior management, to manage submission requirements, mitigate risk, and maintain regulatory commitment compliance
• Monitors global regulatory news and provides interpretation and internal communication as appropriate
• Leads technical and regulatory review forums, to evaluate submission strategy and/or data acceptability. Develops complex global CMC regulatory strategies and networks for alignment across Manufacturing, Quality, GRA, product team(s) and affiliates, as required, to enable timely completion of product registration milestones.
• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, and response to question submissions.
• Effectively collaborates with Health Authority CMC reviewers at US FDA during scientific advice meetings or submission review and interacts with global Health Authorities, as required
• Attends and/or leads industry forums to increase Lilly's visibility
• Participates in forums that share regulatory information across GRA components
• Participates in the development of corporate positions on, and in response to, proposed agency regulations and guidelines.
Minimum Qualification Requirements:
. B.S. Degree in Chemistry, Pharmacy, Biology, Biochemistry, or related Science or Bachelor's with equivalent experience
. Pharmaceutical industry experience in a manufacturing environment, e.g., Manufacturing Sciences and Technology, Quality Assurance, Analytical Laboratories, or Manufacturing (7+ years)
. Prior regulatory CMC experience (minimum 3 years) or equivalent combination of technical and regulatory guidance knowledge
Other Information/Additional Preferences:
Synthetic Peptide/Protein experience preferred
Demonstrated knowledge of CMC regulatory guidance's
Demonstrated strong interpersonal and leadership skills; ability to interact effectively within group and with customer base
Demonstrated ability to organize and analyze detailed information
Demonstrated ability to identify, drive and support business process improvement initiatives
Demonstrated ability to work independently
Demonstrated strong written and verbal communication skills
Demonstrated ability to understand and apply risk analysis concepts
Demonstrated ability to deliver projects according to agree upon timelines
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly