VP EMEA Regulatory Affairs Strategy Organisation in Antwerp, Belgium

VP EMEA Regulatory Affairs Strategy Organisation – 2406197382W

Description

Johnson & Johnson is recruiting for a VP, Regulatory Affairs — Head EMEA Regulatory Affairs Strategy Organization, located in either Beerse, Belgium or a R&D hub-site in Switzerland.

Overview:

The Head EMEA Regulatory Affairs Strategy Organization is a member of the Global Regulatory Affairs organization. The position resides in the assigned region (EMEA) and is responsible for leading Regulatory Affairs Therapeutic Area activities at the EMEA regional level.

The job holder will build and lead an integrated EMEA Regulatory Affairs Strategy Organization at Janssen, covering all therapeutic areas within the J&J Portfolio, including R&D and full life cycle. The EMEA region comprises Europe, Russia and CIS, Turkey, Israel, Middle East, Africa and West Asia.

The jobholder ensures a high level of regulatory professionalism that meets the standards of contemporary European Regulatory Affairs and other EMEA countries’ standards.

The position will drive the long-term growth strategy and vision for regulatory affairs in EMEA. This entails being a strategic partner to R&D and to the EMEA Commercial organization, as well as partnering with Health Authorities and an active participation in trade associations.

The position is responsible for the management of staff in the Therapeutic Areas of the EMEA region (functional management) and to provide guidance in aligning regulatory affairs in EMEA to ensure synergy and integration among countries within the region and globally. The role 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 position is a key management position in EMEA, with important influence both in the region and in Global Regulatory Affairs. The jobholder represents Regulatory Affairs on the EMEA Strategy Leadership Team (ESLT). 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. On behalf of Janssen EMEA Regulatory Affairs, the jobholder is a Member of the Janssen-Cilag International NV (JCI) Board, ensuring compliance with the responsibilities of JCI as the MAH for Centrally approved products in the EU as well as some other, selected products outside EU. This individual is also a key member of the GRA Regional Regulatory Affairs management team, ensuring cross regional integration with global regulatory strategies and processes.

Key Responsibilities

Organization and Talent Development:

• Lead a premier EMEA Regulatory Affairs Therapeutic Area team

• Provide direction for the activities and operating processes of regulatory affairs in EMEA

• Align goals and objectives with TAs 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 EMEA Therapeutic Areas

• Synergize with EMEA Local Operating Companies

• Ensure Heads of LOCs are aligned with TA head strategy and work with peers to ensure appropriate local execution with regard to Regulatory Agency interactions, including adherence to corporate image

• Ensure functional networks between global or regional groups operate optimally to ensure appropriate representation of local regulatory requirements and strategy at Regional and Global level

• Ensure staff are knowledgeable about products 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.

• Develop and deploy metrics to benchmark performance

• Ensure development and/or implementation of processes or procedural documentation to support compliance with global and corporate guidelines and policies for regulatory affairs, including identification of gaps and ensuring appropriate training

• Represent RA in EMEA management groups (ESLT) and contribute to these leadership teams as a competent and skilled business leader

• Represent Janssen EMEA Regulatory Affairs in the JCI Board, ensuring compliance with the responsibilities of JCI as the MAH for Centrally approved products in the EU as well as some other, selected products outside EU

Regulatory Strategy:

• Develop, drive and implement the EMEA Regulatory Strategy in alignment with the Global strategy with the objective of long-term growth

• Provide oversight and guidance on the development and implementation of multi-national/regional registration and compliance strategies that optimize development, registration and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards

• 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 EMEA teams (including Integrated Brand Value Teams (IBVTs) and Therapeutic Area Strategy Teams (TASTs)) 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 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

• Ensure representation in key industry trade associations

• Participate in establishing regulatory policy priorities

Resource Planning and Management; Operational and Compliance Excellence:

• As a member of the Regional GRA regulatory management team, participate in setting strategic and operational direction for the regional regulatory affairs organization

• Provide leadership for business planning activities and process development

• Foster and maintain ongoing communication and alignment with key stakeholders and business partners

• Actively participate in other management and leadership forums

• 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.

• Identify routine operational activities and continuously drive to increase efficiency. Collaborate across GRA groups to streamline processes

• Ensure appropriate levels of support from Global Regulatory Functions

Qualifications

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); 10 years in Regulatory Affairs preferred. 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; adept at building relationships at all levels of an organization

• 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

• Demonstrated ability to multi-task, handle multiple complex priorities. Forward thinking. Ability to manage crisis situations

• 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’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 dynamics

• Ability to stay abreast of regulatory developments in the region and assess business impact

• Ability to drive long-term growth strategy and vision for EMEA RA. Deep understanding of the competitive landscape

• 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

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. Develops and deploys metrics to measure and report performance of the regulatory affairs in the region.

Independence in decision-making regarding regional strategy in development plans and implementation tactics. Define operational priorities and tactics. Resolve conflicts in priorities in consultation with business partners and internal customers. Makes informed complex decisions in situations with multiple, ambiguous objectives and constraints. Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards and regulations in drug regulation and personnel practices, but will not be explicitly circumscribed by these.

Able to analyze complex information and situations and to formulate clear direction; Presents issues and solutions to senior management and Health Authorities.

Other

Independence/Autonomy/Reporting Relationships:

• Reports to VP Head Regional Regulatory Affairs. Dotted reporting relationship to Head EMEA Strategy & Operations (ESO)

• Independent and autonomous, located remotely from manager. Independent in daily activities with limited managerial oversight. Position receives instruction only as to broad objectives to be achieved and in view of alignment with overall company and GRA strategy. Position makes determination of issues that require management review or input.

Responsibility for Others:

• Responsibility for a department of approx. 100 employees, reporting in R&D. Responsible for directing and managing a virtual team with matrixed reporting relationships.

• Staffing responsibilities – hiring, staff placement, termination decisions

• On-going resource management and allocation

• Ensures training of department staff members

Working Relationships/Interfaces:

• Works with EMEA TA Heads and TA liaison staff in development of project strategies and in the development of department shared practices and knowledge sharing. Interacts with and provides ongoing coaching and feedback to regulatory staff in the region

• Interacts with R&D organizations, all GRA groups, with Regional commercial management and ESLT

• Interacts with others on Regional regulatory management team and other GRA staff

• Interacts with other key business partners across J&J IM e.g. Leaders in Safety and Quality organization, Supply Chain etc.

• Interacts with Finance, HR, IT and other relevant business partners

Working Conditions/Travel Requirements:

Position is located in either Belgium or Switzerland. Must be able to travel internationally and regionally – frequent travel within the region (approx.. 15-20%) is required, with occasional intercontinental travel

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.

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.careers.jnj.com.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations Europe/Middle East/Africa-Switzerland

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Regulatory Affairs

Req ID: 2406197382W