EMEA (preferred locations : Netherlands/Belgium or Ireland)
- Work closely with the senior leadership team in developing and proposing scientific direction in key areas to drive a high performing, scientific oriented organization and consistent application of practices, policies, systems and programs
- Lead and or contribute to selected, complex projects within CMC RA developing a business-oriented CMC strategy.
- Provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s) as needed
- 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 as needed
- 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
- Support the senior leadership in driving implementation of strategic plans
Sphere of Authority
- Own or support CMC development and commercial product regulatory strategy ensuring compliance with global regulatory requirements over the lifecycle of the product and 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 as needed.
- Provides Technical input to help clarify or improve CMC Regulatory strategy and assist teams to resolve issues.
- BS in biological or pharmaceutical 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 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 effectively 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
- Ability and willingness to acquire the right level of scientific understanding to solve current business needs and to provide guidance for innovative solutions for current and future needs
Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Biologics (7266)