Job Description
Regulatory Scientist: Lead CMC Regulatory Scientist
We are seeking a highly skilled Regulatory Scientist to lead our CMC Regulatory Scientist team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a matrix environment.
Job Description
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.
Main Responsibilities:
- Regulatory Expertise: Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations.
- Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers.
- Ensure successful preparation of CMC dossiers and variation packages to support product submissions.
- Provide regulatory leadership and support for products listed as the primary responsibilities.
- Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as TS/MS (process and technology transfers), manufacturing, quality control and quality assurance.
- Be a responsible party for preparing CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
- Partner with the GRA-CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countries.
- Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner.
- Partner with RDE CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicable.
- Manage authoring and content reviews of simple Rt Qs.
- In conjunction with RDE CMC Regulatory Associates and GRA-CMC Regulatory Scientists, may be involved in the management of some GMP documents, if applicable.
- Review/Approve regulatory documents such as: full and core CMC Dossiers, variation packages, post-approval commitments with health authorities and answers to questions received from health authorities.
Key Skills:
- Strong knowledge of regulatory and compliance guidelines within pharmaceuticals / biopharmaceuticals.
- Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance.
- Proven ability to effectively influence within and beyond the GRA organization.
- Communicates effectively, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
- Fully proficient in RIM and in using common Microsoft applications to create and present work.
- Good organizational skills, with the ability to prioritize and be self-motivating.
- Work well collaboratively within a team, or as an individual contributor.
- Possesses excellent attention to detail and ability to effectively prioritize.
If you are a motivated and detail-oriented Regulatory Scientist with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.