Job Description

Janssen Research & Development, LLC is recruiting for a Director, Regional Business Support, Global Regulatory Affairs (GRA). The preferred locations are Raritan NJ (U.S.), Beerse (Belgium), High Wycombe (United Kingdom) Leiden (Netherlands). Other locations may be considered.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Our company thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

This position oversees the development, implementation and ongoing evaluation of the operational and strategic capabilities of the integrated Regional Regulatory Team. It leads business process optimization, system deployment and people development activities required to achieve optimal team performance. The position has global accountability while serving as the regional advocate for Regional RA on major initiatives. It rapidly adapts to a changing environment and makes best use of process, technology and people resources in ways that are innovative, thereby enhancing value to internal/external customers. The position works collaboratively and builds alliances with all parts of the business, including central RA functions, to leverage expertise, resources, processes and tools. Working with the Regional RA senior leadership team, it drives key initiatives to enhance RA capabilities across regions, with particular emphasis on local/global RA collaboration and integration.

Responsibilities will include but are not limited to:

* Build cross-regional process and portfolio capabilities that drive tangible value creation across all components of the regional and local RA organization. Use analytics to track progress in areas that include acceleration, efficiencies, resource optimization.
* Accountable to provide program / project management / process / organizational change leadership for cross-regional strategic priorities sponsored by the Regional SLT. Align goals and objectives consistent with an integrated Regional RA portfolio program. Lead and/or participate in cross-regional initiatives as assigned.
* Collaborate with central RA functions to leverage global expertise, resources, processes and tools across the LOCs and regions. Develop and negotiate support agreements as required.
* Support, coach, mentor, and foster talent development across the regional RA team.
* Serve as an effective change leader. Align stakeholders, champion the change, communicate, and ensure people are well prepared and can work effectively within new structures and operating models.
* Leverage recent/ongoing Regulatory Information Management initiatives to achieve significant business benefits via the deployment of new or enhanced technology-enabled processes.
* Establish mechanisms and monitor the overall performance of the Regional RA organization through the use of metrics (scorecards, dashboards).
* Provide leadership and serve as an advocate for Regional RA on global initiatives that lead to new capabilities, efficiencies, speed and / or quality.
* Actively participate as a member of the Regional RA Senior Leadership Team.
* Facilitate annual business planning data collection and contribute to cross-regional spend/investment strategies in RA.
* Support the development and implementation of cross-regional registration / lifecycle strategies for new and current products taking into consideration current and proposed changes in registration requirements and standards.

This position reports to the Vice President, Regional Regulatory Affairs.

Business Imperatives

The Regional Regulatory Affairs team is broadly based in Europe, Middle East and Africa, Asia-Pacific, Latin-America and the US. It is a key team within Global Regulatory Affairs, and it collaborates closely with internal and external local, regional and global stakeholders, including other R&D; and commercial functions. The team continuously strives to optimize its effectiveness and efficiency in a complex global healthcare and regulatory environment, to achieve fast regulatory approvals for new products and to enhance life-cycle management. Decision-making and problem-solving in this role include

* Proactively analyze customer needs, and develop, recommend and implement effective solutions. Use critical thinking and problem-solving skills to develop best practices.
* Prioritize opportunities, including process and information technology investments, consistent with business objectives.
* Allocate resources to areas of greatest business need. Decide where to focus critical resources. Continuously assess needs and decline or stop non-critical projects and activities.
* Sequence and phase project activities to manage change, reduce risk, and promote uptake of new processes and systems.
* Develop recommendations regarding staffing, organization structure, functional organization, and task distribution.
* Ensure that decisions are made in compliance with regulatory guidelines and company compliance standards.

Leadership Imperatives

* Make complex decisions in situations with multiple and ambiguous objectives and constraints.
* Develop collaborative solutions cross-regions by building and leading cross-functional / global teams.
* Effectively handle employee relations issues and resolves them before they escalate.
* Stretch self and others to make sense of new evolving world.

Qualifications
Qualifications

* Minimum BA/BS degree is required; an advanced degree, MS, MBA, or higher is a plus.
* At least 10 years of health regulated industry experience is required
* At least 5 years of experience in leadership roles in a cross-functional setting is required
* At least 3 years of exposure to and general understanding of drug development and registration/regulatory processes is required.
* Broad understanding of the global pharmaceutical business and emerging markets is required.
* Direct experience working in or for one or more of the following global markets within the regulatory, commercial strategy, or clinical development environment is required: Asia-Pacific, Latin-America, or EMEA (Europe, Middle East and Africa).
* A proven track record applying international competitive business intelligence and dynamics is required.
* Demonstrated team leadership ability is required.
* Excellent interpersonal skills; adept at building relationships at all levels of the organization.
* In-depth cultural awareness and understanding of business etiquette is essential.
* Good understanding of drug development and commercial business needs, and ability to design and deploy processes that accommodate these business needs is required.
* Broad-based experience in program/project management, change management, and process design is required, as well as demonstrated success in implementing organizational improvement.
* Previous success using analytics to track progress in areas that include acceleration, efficiencies, capacity planning and resource optimization is required.
* Training and demonstrated success in Lean, six sigma or comparable process improvement methods and tools is desirable.
* Facility in a regional language spoken in Asia-Pacific or Latin-America (e.g., Chinese, Spanish), or demonstrated multi-lingual ability is desirable.

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.

Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
Netherlands, United States, Belgium, United Kingdom, United States-New Jersey-Raritan, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2005878766W