Senior Scientist CMC Regulatory Affairs

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are currently seeking a motivated Senior Scientist in CMC Regulatory Affairs to join our dynamic team. This role can be based in Beerse, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with 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):

East Coast United States - R-022395

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

Position Summary:

The successful candidate will play a critical role in supporting a broad range of regulatory activities within the Chemistry, Manufacturing, and Controls (CMC) area of Global Regulatory Affairs. This position will involve collaboration with various professional colleagues, including CMC/Supply Chain team members, Therapeutic Area Leaders, and GRA management.

Main Duties and Key Responsibilities:

• Support the alignment of CMC regulatory strategy with global/regional/commercial regulatory objectives.
• Collaborate with senior level CMC RA colleagues to ensure connectivity to overall global regulatory strategy.
• Develop CMC content and dossier plans under the supervision of senior CMC RA personnel.
• Assist in the preparation of global dossiers and variations for submission to Health Authorities.
• Manage CMC submissions for renewals, annual product submissions, and inquiries from local partners and health authorities.
• Coordinate and compile CMC country-specific documents required for global submission approvals.
• Oversee the global submission plan and timeline.
• Contribute to the implementation of global CMC regulatory strategies and dossier plans through collaboration with CMC RA teams.
• Prepare responses to Health Authority questions or communications in line with global product strategy.
• Alert CMC Regulatory Affairs Management to issues affecting registration, compliance, and product lifecycle management.
• Track submission-related activities across all necessary CMC RA systems.

Leadership Competencies:

The Senior Scientist in Regulatory Affairs should:

• Proactively identify and respond to problems and opportunities.
• Consistently deliver results that meet or exceed expectations, focusing on driving customer value.
• Make decisions based on factual evidence.
• Challenge the status quo to find more efficient and effective ways of working.

Qualifications:

• University degree in engineering, biological, pharmaceutical, or chemical sciences with a minimum of 3 years of relevant experience (preferred), which may include post-graduate education and/or experience in the pharmaceutical or healthcare industry.
• Prior experience in drug development, analytical development, or manufacturing is preferred, with a solid understanding of biology, chemistry, and/or engineering. Regulatory experience in this area is encouraged.
• Familiarity with global CMC regulatory procedures and guidelines.
• Experience working in project teams and/or matrix organizations.
• Excellent oral and written communication skills.
• Ability to thrive in a collaborative team environment as an individual contributor.
• Proficient in spoken and written English.