SENIOR DIRECTOR, EMEA REGULATORY AFFAIRS TA HEAD NEUROSCIENCE/CVMRETINA

The EMEA Regulatory Affairs Organization within Johnson & Johnson is recruiting for a Senior Director EMEA Regulatory Affairs Therapeutic Area Leader Neuroscience/Cardiovascular & Metabolism and Retina, located in either Beerse, BE, High Wycombe, UK or Leiden, NL.
Overview.
This position is a key role within the Global Regulatory Affairs organization and resides in the assigned region (EMEA) with responsibility for leading the EMEA Regulatory Affairs Therapeutic Area activities for Neuroscience/Cardiovascular & Metabolism and Retina (NS/CVMR).
The EMEA region comprises Europe, Russia and CIS, Turkey, Israel, Middle East, Africa and West Asia.
The portfolio includes products to treat various types of diseases within all these therapeutic areas, at different stages of the product life cycle, from very early phase into later life cycle.
The jobholder ensures a high level of regulatory professionalism that meets the standards of contemporary European Regulatory Affairs and other EMEA countries’ standards.
This role will drive the long-term growth strategy and vision for regulatory affairs in EMEA for NS/CVMR portfolio, be a strategic partner to R&D and to the EMEA Commercial organization and will partner with Health Authorities.
The position is responsible for the management of staff in the NS/CVMR EMEA RA Therapeutic Area (functional management), ensures that the organization is optimally run to support the needs of the global/regional regulatory functions such that products are expeditiously and compliantly developed, submitted and approved within the region.
The position ensures understanding and alignment of global, regional, and local goals and objectives.
The jobholder represents Regulatory Affairs on the NS/CVMR EMEA Therapeutic Area Strategy Team (TAST) and on the Global NS/CVMR Reg affairs leadership teams.
The jobholder contributes to key EMEA governance issues including business decisions, yearly Business Planning, Long Range Financial Planning, Integrated Evidence Generation planning, people management, product prioritization, etc.
Key Responsibilities.
Organization and Talent Development.
Lead a premier EMEA Regulatory Affairs Therapeutic Area team Align goals and objectives with NS/CVMR TA and EMEA commercial organization; ensure harmonized approach for input into product development, compliance, training, career development, etc.
Provide line management, supervision and coaching of regulatory staff in the NS/CVMR EMEA Therapeutic Area Synergize with EMEA Local Operating Companies.
Ensure Heads of LOCs are aligned with NS/CVMR TA strategy and work with peers to ensure appropriate local execution with regard to Regulatory Agency interactions, including adherence to corporate image Ensure staff are knowledgeable about NS/CVMR portfolio and are provided with appropriate technical/therapeutic area training Develop and execute an inclusive talent strategy to ensure optimal talent development, build a pipeline of future regulatory leaders; Support, mentor and foster talent development.
Represent RA in EMEA TA Strategy Teams (TAST) and contribute to these leadership teams as a competent and skilled business leader Work with GRA compliance groups, as well as with EMEA compliance functions to implement processes, standards and training that ensure a high level of regulatory compliance Ensure that systems are in place and staff are trained to track MAH obligations, HA queries, CMC questions, CCDS changes, product approvals, submissions excellence, etc.
Conduct financial and resource management planning for the TA Regulatory Strategy.
Develop, drive and implement the EMEA NS/CVMR Regulatory Strategy in alignment with the Global strategy with the objective of long-term growth Provide input to critical submission documents throughout the product lifecycle to ensure they support the regional requirements Maintain expert knowledge in EMEA regulatory requirements and ensure that staff has required expertise Provide guidance to staff in developing options to manage risks and overcome barriers Provide input into decision making and processes that impact registration and commercialization of products in EMEA Ensure regulatory participation in IBVTs (Integrated Brand Value Teams) and ensure appropriate staffing Ensure that Health Authority engagement strategies are defined for proactive and reactive communications Health Authority and Key Stakeholder Interactions.
Ensure optimal relationships with key EMEA Regulatory Agency leaders; Shape and appropriate influencing of the regulatory stakeholders Establish relationships with local Health Authorities and support regional regulatory staff in their relationship and interactions with HAs Ensure that staff are provided with appropriate technical/therapeutic area support for HA interactions Ensure excellent collaborative relationships with key stakeholders, including commercial, medical affairs, HEMAR, and R&D partners Participate in establishing regulatory policy priorities Qualifications Education and Experience.
Minimum of an advanced degree in science/health-related field Minimum of 15 years of relevant pharmaceutical industry experience (for example, in clinical research, regulatory affairs or medical affairs) of which at least 7+ years in Regulatory Affairs.
Must possess a good understanding of R&D and commercial processes and business needs.
Experience in a local operating company and/or regulatory agency is a plus Working knowledge of regulations and guidelines related to drug development and registration.
Breadth of global regulatory affairs experience in drug development and commercialization (for example, experience in multiple therapeutic areas, multiple phases of drug development, multiple countries) Global regulatory or drug development experience, with experience in contribution to drug development strategies Experience with Health Authority interactions.
Ability to act as company spokesperson with Health Authorities Experience specifically in the region is required and relevant global experience will be considered Skills.
Demonstrated leadership, organizational and people management skills.
Track record of staff development.
Able to develop highly motivated and talented people and successful talent pipelines Excellent English verbal and written communication skills, ability to work and thrive in a multi-cultural environment and ability to work in a multi-discipline matrixed environment are required Excellent interpersonal skills In-depth cultural awareness and understanding of business etiquette Facilitation skills to generate consensus among key customers and stakeholders.
Strong influencing skills Excellent communication skills Delivery of results and experience accomplishing objectives through people Ability to influence senior level management Demonstration of long-term strategic insight and innovative thinking Required Technical Competencies & Knowledge Regulatory Strategy.
Understanding of regional and local laws, regulations and guidance in the region related to full drug life cycle.
Ability to interpret these and understand applicability to J&J IM’s portfolio in the context of the scientific and commercial environment Deep understanding of drug development and lifecycle management activities Broad understanding of the global pharmaceutical business and the EMEA region, including the regulatory environment, the commercial strategy, clinical development, broader R&D, supply chain and competitive landscape and dynamics Ability to stay abreast of regulatory developments in the region and assess business impact Solid understanding of the scientific and medical principles applicable to medicinal products Ability to evaluate submission content in view of product regulatory strategy, HA requirements and commercial needs Knowledge of global and local labeling requirements HA and Key Stakeholder Interactions.
Ability to guide others in engagement strategies with Health Authorities Ability to communicate and interpret HA processes and practices to business partners and subordinates Experience in conflict resolution between the company and 3rd parties (HAs, licensing partners, etc.) Comprehensive understanding of the regional commercial business and its business partners Resource Planning and Management.
Able to apply project management principles to ensure smooth department operations (HR related matters, budget management, time, etc.) Managerial (line management) and coaching/mentoring skills Required Leadership Competencies.
Live Our Credo - Demonstrates and inspires the behaviors that reinforce Our Credo Connect - Cultivates meaningful external relationships and partnerships outside of J&J, adding value and insights for the enterprise to proactively uncover critical unmet needs and turn them into new opportunities Shape - Translates insights into innovative and viable products or solutions, creating value; challenges the status quo and leads change management activities, creating positive change; takes and properly manages risks, while maintaining the highest standards of quality and compliance, contributing to value creation Grow - Develop self and others to reach their goals and engage in personal development discussions.
Engages in open and honest conversations.
Drives performance by managing energy and taking ownership for outcomes DE&I - Showcase and apply behaviors in line with DE&I principles Decision making and Problem Solving - Management decisions regarding staffing, organizational structure, functional organization, and task distribution.
Authority to hire, re-assign and terminate (for cause) personnel within the reporting structure and business plan.
Effectively handles employee relations issues.
Develops regional regulatory strategic objectives, goals and performance measures.
Reporting Relationships.
Reports to VP Head EMEA Regulatory Affairs Strategy Organization.
Dotted reporting relationship to EMEA NS and EMEA CVMR TAST Leaders Working Conditions/Travel Requirements.
The position is preferably based in one of the main EMEA-RA TA-locations (High Wycombe (UK), Leiden (NL), Beerse (BE)).
Must be able to travel internationally and regionally - travel within the region (approx.
5-10%) is required, with occasional intercontinental travel Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.