Exp. Scientist, CMC Regulatory Science

Position Summary: 

The Experienced Scientist Regulatory:

• is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs. 

• may interact with professional colleagues, including the CMC/Supply Chain team members, Therapeutic Area Leaders, and GRA management as project and functional objectives and needs dictate.

• works with other CMC RA personnel to manage and resolve any issues.

Main duties and responsibilities:

The Experienced Scientist Regulatory:

• assists in ensuring the CMC regulatory strategy is in alignment with the global/regional/commercial regulatory strategy.  Further assures connectivity and alignment to the overall global regulatory strategy through partnership with other senior level CMC RA personnel.

• Under the supervision/collaboration of more senior CMC RA personnel

• develops CMC content and dossier plans

• assists in the preparation of global dossiers/variations for submission to Health Authorities

• assists with CMC submissions for renewals, annual product submissions and questions from LOC partners/health authorities/other J&J partners

• coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions

• executes the oversight of the global submission plan and timing

• contributes to the implementation of global CMC regulatory strategies and dossier plans by collaborating with other CMC RA personnel

• assists in preparing responses to HA questions or other HA communications in alignment with the global product strategy

• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.

• Manages the inputs/tracking for submission related activities in all required CMC RA systems

• Contributes to the implementation of the global CMC regulatory strategies

Leadership Competencies:

The Experienced Scientist Regulatory:

• Proactively senses and responds to problems and opportunities

• Consistently delivers results that meet or exceed expectations; keeps the focus on driving customer value

• Makes decisions based on facts

• Challenges the status quo to identify ways of doing things better and more efficiently

Education and Experience:

• University degree in engineering, biological, pharmaceutical, or chemical sciences with generally a minimum of 1 year of experience (preferred) inclusive of post graduate education and/or pharmaceutical or health care industry experience

• Prior experience in drug development, analytical development or manufacturing preferred with solid understanding of biology, chemistry and/or engineering.  Regulatory experience within this scope encouraged

• Experience with global CMC regulatory procedures and guidelines/requirements

• Experience in working in project teams and/or a matrix organization

• Excellent oral and written communication skills.

• The ability to work successfully within a collaborative team environment as an individual contributor 

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

Belgium - Requisition Number: R-069961

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.