Principal Scientist- Global Regulatory Affairs

Principal Scientist- Global Regulatory Affairs-CMC

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 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 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 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 Provides comments on draft guidance’s, as applicable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;

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