Principal Scientist - Global Regulatory Affairs - CMC

Eli Lilly Benelux

Limerick, Ireland

Purpose:

The purpose of the Principal Scientist - Global Regulatory Affairs - CMC role is to provide strategic, tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships and by a demonstrated ability to establish and/or to promote/refine key regulatory CMC positions and to effectively influence development, manufacturing, and GRA leadership on these positions.

Responsibilities:

The Principal Scientist - Global Regulatory Affairs-CMC:

Will oversee the preparation and documentation of specified regulatory submissions;
Provide regulatory leadership and direction for products listed as primary responsibilities;
Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control and quality assurance;
Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner;
Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations;
Provides the necessary CM&C commitment information to site personnel;
Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.);
Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols;
Will participate in Lilly’s Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives;
Will participate, where applicable, in industry association meetings (e.g. PCI) and Lilly groups to benchmark and influence revisions to guidance’s;
Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance’s, as applicable;
Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.

Minimum Qualification Requirements:

Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required;
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.

Additional Skills/Preferences:

The applicant should have:

Strong knowledge of regulatory and compliance guidelines within pharmaceutical/biopharmaceutical manufacturing;
Good attention to detail and demonstrated effective teamwork skills;
Proven ability to effectively influence within and beyond the organization;
Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.

The role is most suited towards a conscientious individual who has excellent verbal and written communication skills and, is fully proficient in using common Microsoft applications to create and present work. The successful applicant must have good organizational skills, with the ability to prioritize and work on their own initiative, both collaboratively as a team member and also on individual projects.

Additional Information:

The role holder:

Will facilitate a collaborative environment with all internal and external stakeholders;
Stay abreast with current technical and regulatory trends and continually develop knowledge by attending training courses, conferences or association meetings and share such information with other members of the group or company to increase their awareness;
Lead and/or contribute corporate improvement efforts at local and international level.

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