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We are searching for the best talent for a CMC RA Director to be in Warsaw, Poland.

Principle responsibilities

• Work closely with the senior leadership team in developing and proposing direction in key areas to ensure a high performing organization and consistent application of practices, policies, systems and programs
• Planning, organizing, and directing resources and activities within CMC RA. Drive the execution of identified projects and workstreams
• Lead selected initiatives within CMC RA / GRA
• Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s)
• Identify, prioritize and drive projects and workstreams. Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers
• Participates in and conducts due diligence/licensing evaluations as needed
• Responsible for training, coaching and development of the team members
• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Senior Management
• Represents CMC RA on Cross Functional Governance Committees
• Serves as a SPOC/SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise
• Creates engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills
• Enables a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group
• Support the senior leadership in driving implementation of strategic plans

Sphere of Authority

• Support their team to ensure 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)
• Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope. Escalates critical issues to CMC RA management
• Effectively and tactfully communicates with health authorities; maintain good rapport and credibility.
• Reviews and approves CMC regulatory dossiers for global submissions throughout the product lifecycle
• Responsible for talent and development management strategy in line with the GRA strategy within his/her group

Position Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 12+ 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
• Successful experience in leading a diverse community of professionals in a global and matrix environment. Seasoned leader, decision maker and constructive challenger
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Proven track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy
• Strong attention to detail with high-level verbal and written communication skills
• Makes decisions based on facts and sound scientific principles Ability to interact with all levels in the organization
• Communicates cross-functionally and cross-company; presents and defends CMC management-approved regulatory strategy to project teams; recognizes and accounts for global regulatory impact
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results
• Experience leading health authority interactions
• Strong knowledge of global regulatory laws, regulations, guidance and submission routes pertaining to drugs from early development to commercial maturity
• Good understanding of competitors in the area and what they are doing in early/late development