Principal Scientist, CMC Regulatory Affairs

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

Johnson & Johnson Innovative Medicine is recruiting a Principal Scientist in Global CMC Regulatory Affairs - Synthetics, Established Modalities., covering both pre- and post-approval activities. This position is located in Warsaw, Poland.

The Principal Scientist in CMC Regulatory Affairs will be responsible for the following:

• Participates as the CMC (chemistry, manufacturing and control) Regulatory Lead on CMC/Value Chain Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
• Actively participates on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.

• Develops and executes global CMC regulatory strategy for one or more synthetic drugs and/or delivery device, meeting .

• Leads the preparation of regulatory dossiers for submission to Health Authorities.

• Develops and gets buy-in on CMC regulatory strategy for Health Authority responses as needed.
• Participates in selected initiatives within CMC RA / GRA
• Participates in and conducts due diligence/licensing evaluations as needed

• Drives a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management

Sphere of Authority

• Ensures the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP)
• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).

• Refines regulatory strategies as new data become available.

• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Develops and updates contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
• Effectively and tactfully communicates with health authorities; maintain good relationship and credibility.
• Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle.
• Provides accurate regulatory assessments of CMC changes and executes regulatory planning and implementation.

Position Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree preferred
• Demonstrated ability to communicate regulatory requirements.

• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry

• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.

• Strong attention to detail with high-level verbal and written communication skills

• Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.

• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results

• Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
• Good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• Some understanding of competitors in the area and what they are doing in early/late development

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

zł205,000.00 - zł354,200.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.