At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France, Latina, Italy, Leiden, Netherlands, Neuss, North Rhine-Westphalia, Germany, Zug, Switzerland

Job Description:

Innovative Medicine Regional Regulatory Affairs

Head of European Local Operating Company Regulatory Affairs and Regional Regulatory Affairs Reliance Lead

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for Head of European Local Operating Company Regulatory Affairs and Regional Regulatory Affairs Reliance Lead to be in based in either Beerse – Belgium, Zug/Allschwil – Switzerland, Neuss – Germany, Issy Les Moulineaux – France, High Wycombe – United Kingdom, Latina – Italy, Leiden - Netherlands.

Purpose: The Senior Director Head of European Local Operating Company (LOC) Regulatory Affairs (RA) and Regional Regulatory Affairs (RRA) Reliance Lead is a member of Global Regulatory Affairs (GRA) organization. The position resides in the RRA organization and is responsible to drive the strategic agenda for the Regulatory Affairs Function in G5 and Mid-Sized Market (MSM) LOCs, in support of the EMEA Commercial business, for initial and lifecycle submissions for all therapeutic areas within the J& J IM Portfolio. In addition, the role will be the Reliance Lead for Regional Regulatory Affairs, in close partnership with GRA TAs. RODI and CMC RA.

The job holder is responsible to drive and implement the G5/MSM regulatory strategy for the J& J IM portfolio, for harmonising European LOC RA responsibilities wherever relevant, showcasing role of LOC RA in external influencing, business partnering, submissions/approvals in the non-EU European countries and contributing to new product & indication launches across G5 and MSM. The role includes people line management for approximately 100 reports (mix solid/dotted line) in the European LOCs and indirect budget responsibilities for approx. $20M.

In view of the increasing importance of Reliance procedures in the Regional Regulatory Affairs organisation and in order to accelerate Major Submissions and consequentially, patient access across the regions, the job holder will lead and take accountability to develop an optimised process for reliance procedures (ORBIS and ACCESS and any other reliance procedures), ensure it is rolled out and consistently applied across our portfolio and countries and remain the Business Lead for this process subsequently.

The position is responsible for working with the EMEA Strategy Organisation and the Emerging Markets organisation to ensure strategic alignment across EMEA, in view of submission strategies, operational processes and compliance. The position establishes priorities, allocates resources, provides line management, supervision, coaching, talent development and training for all its staff. The position works collaboratively and builds alliances and strong engagement with GRA partners (e.g., TAs, RODI, CMC RA, Global Labeling), Leaders in Safety and Quality organizations, Supply Chain and Regional Commercial to achieve superior business support thereby enabling RRA to deliver on its mission. In addition, the role benchmarks G5/MSM business performance against competitors and is aware of emerging industry trends.

The jobholder is a key member of the Regional Regulatory Affairs management team, the Commercial MSM LT and interacts with G5 MDs on an ongoing basis.

You will be responsible for:

Organization and Talent Development

• Lead a premier European (i.e. EMEA non-EM) Regulatory Affairs LOC RA team (solid and dotted line reporting), with focus on a streamlined and aligned way of working across the countries and clusters and for stakeholders
• As a member of the RRA management team, participate in setting strategic and operational direction for the local regulatory affairs organization
• Align goals and objectives with TAs and commercial organisations; ensure harmonized approach for input into product development, compliance, training, career development, etc.
• Actively shape and contribute to G5/MSM business as a strategic member of Commercial MSM LT and via G5 MD interactions
• Provide line management, supervision and coaching of LOC RA staff in organization, ensure staff are knowledgeable and 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
• Drive and leverage cross-country synergies and efficiencies and support the global regulatory and regional teams by providing expertise
• Provide oversight and guidance on the implementation of regulatory strategies and regulatory submission plans for G5/MSM markets, in line with R& D, regional and local business objectives, for the entire J& J IM portfolio
• Maintain expert knowledge across the EMEA region and ensure staff has required expertise
• Provide oversight and guidance on the development and implementation of multi-national/regional registration and compliance strategies of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards
• Provide guidance to staff in developing options to manage risks and overcome barriers
• Ensure that submission tactical plans and timelines are negotiated with and communicated to global, regional and local stakeholders
• Ensure strategic alignment and effective execution of Global Filing and Launch Strategy (GFLS) processes
• Provide labeling implementation and operational support as needed (e.g., deviations, variations, translations, artwork)

Reliance Lead

• Accelerate Major Submissions in specific countries across all regions, lead and take accountability to develop an optimised process related to reliance procedures (ORBIS and ACCESS and any other reliance procedures), ensure it is rolled out and consistently applied across our portfolio and countries and remain the Business Lead for this process subsequently
• Collaborate extensively across all regions, with all key GRA stakeholders and Commercial partners to develop and implement the optimal approach

Resource Planning and Management; Operational and Compliance Excellence and Process Support

• Foster and maintain ongoing communication and alignment with key stakeholders and business partners
• Work with GRA compliance groups to implement processes, standards and training and ensure a high level of regulatory compliance

External Environment

• Support preparations for meetings with Health Authorities as appropriate, along with relevant GRT and CDT members and GRA groups (EMEA and Global TAs, C-ROSS, CMC RA and RODI)
• Shape the regulatory environment through active engagement with local HAs and Trade Association etc
• Facilitate and support leading roles of cluster/local RA leaders in industry associations
• Monitor, assess and communicate the changing regulatory environment, existing legislations and guidelines on clinical development plans and registration strategy

Required Technical Competencies & Knowledge

Regulatory Strategy

• Ability to interpret EMEA and local laws, regulations and guidances related to drug development and life cycle and their applicability to J& J’s portfolio in the context of the scientific and commercial environment
• Deep understanding of drug development and lifecycle management activities
• Ability to stay abreast of regulatory developments in the EMEA region and assess business impact
• Ability to evaluate submission content in view of regulatory strategy, HA requirements and commercial needs
• Knowledge of global and local labeling requirements
• Experience in conflict resolution between the company and 3rd parties (HAs, licensing partners, etc.)
• Understanding of the regional commercial business and business partners

Reliance Lead

• Solid/Deep understanding of existing Reliance procedures (e.g., ORBIS, ACCESS, WHO, Dependencies), interdependencies and opportunities

Submissions, Labeling and Data management

• Knowledge of HA procedures and HA review practices in the regions
• Knowledge of laws, regulations and guidances as they apply to submissions and as they impact regulatory outcomes
• Understanding of local and global labeling requirements and how these translate into labeling language
• Understanding of labeling deviations, variations, translations and artwork processes

Resource Planning and Management; Operational and Compliance Excellence and Process Support

• Able to apply project management principles to ensure smooth department operations (including budgets)
• Managerial (line management) and coaching/mentoring skills
• Deep understanding of GRA/RRA processes, systems and compliance needs

Qualifications / Requirements:

Education and Experience

• Minimum of an advanced degree in science/health-related field
• Minimum of 15 years of relevant pharmaceutical industry experience; 10 years in Regulatory Affairs preferred. Must have a good understanding of R& D, commercial processes and business needs as well as Regulatory Operations. Experience in a local operating company and/or regulatory agency is a plus
• Experience in execution and implementation of regulatory strategies
• Working knowledge of regulations and guidelines related to drug development and registration
• Regulatory or drug development experience, including contribution to drug development strategies
• Experience with Health Authority interactions. Ability to act as company spokesperson with Health Authorities
• Experience specifically in the regions 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 language 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.
• Delivery of results and experience accomplishing objectives through people
• Ability to influence senior level management
• Demonstrated ability to handle multiple complex priorities. Forward thinking. Ability to manage crisis situations
• Demonstration of long-term strategic insight and innovative thinking

• Position is located in one of the major hubs in Europe and requires travel within the European region (approx. 15-25%) and internationally as needed.

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