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Note: this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements (China R-108931, Japan R-108932, Singapore R-107981). Applications to any or all of these postings will be considered as a single submission.
Position Summary
The Regulatory Affairs Director is a member of the Global Regulatory Affairs organization and is the regulatory regional office for the Immunology portfolio, reporting to the therapeutic immunology head. This product responsibility includes leadership responsibility for Nipocalimab and the early portfolio.
The position provides strategic leadership input for the local regulatory affairs department in Asia Pacific and successfully implements the regional and local regulatory strategy for products/projects in the assigned therapeutic area. It is also responsible for providing region or country input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region. The position provides leadership and portfolio review for all early portfolio assets before they go into pivotal Phase 3 study.
The position provides leadership together with the local RA team to ensure adequate preparation for health authority meetings, and attends and presents to health authorities where necessary.
As immunology is a therapeutic area with many new diseases, the position's technical expertise to guide the development and understanding of new diseases for the local regulatory affairs team and extended team is also important.
The position provides high-level oversight for product variations, including labeling changes, supplements, and amendments; timely responses to Health Authority inquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business. The position resides in the Asia Pacific region.
Principal Responsibilities
•Provides direction for the regulatory activities related to products/projects in the Immunology therapeutic area. Works with "head office-based liaisons" and local operating companies to define and implement the regional and local strategy for assigned products.
•Manages development and implementation of multi-national/regional regulatory 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.
Regulatory Strategy and Expertise
•Expedites Regulatory approval of new products, new indications and line extensions via participation in regional cross-functional team(s) to provide early regional regulatory inputs identifying barriers and needs to shape the global developmental plan.
•Provides technical expertise and guidance to local affiliates on strategies to accelerate submissions/approvals.
•Provides input into label and TPP, leads strategic discussion on label pre- and post-registration.
•Provides regional implementation and regulatory-based advice on new and updated Company Core Data Sheets.
•Maintains expert knowledge in regional regulatory requirements and ensures staff are expert in country- and product-specific regulatory requirements.
Health Authority, Operating Companies, and Business Partner Interactions
•Manages regulatory interactions with local operating companies and regional functions.
•Serves as point of contact with local operating companies.
•Ensures excellent collaborative relationships with key stakeholders including staff in the region, R&D and business partners, and senior management.
•Interacts with local operating companies on individual products/processes.
•Facilitates discussions with local operating companies on regional or global regulatory issues, as required.
•Provides guidance to local operating companies to determine timing and strategy for regional HA meetings; participates in preparations for interactions with HAs and assists operating companies with these interactions.
•Acts as the primary contact with multifunctional regional teams such as Commercial Strategic Marketing, Market Access, supply chain, legal and patent.
•Leads regulatory activities on regional cross-functional teams.
Regulatory Submissions
•Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
•Ensures maintenance of content plans for submissions in the region, including clinical trials and registration submissions.
•Reviews and provides input to critical submission documents.
•Delivers on business critical regulatory submissions in accordance with development and/or post-marketing priorities and timelines.
•May be invited to participate in "Rapid Response Teams" to ensure appropriate and timely responses to HA questions; provides clarification regarding HA questions and input to response strategy.
•Ensures tracking of submission and approval milestones.
•Ensures tracking of regional post-approval commitments and appropriate follow-up actions with the C-ROSS MS team.
People Management
•Will have people management/oversight responsibilities for regional regulatory staff, and regulatory staff in LOCs, if applicable.
•Provides coaching and guidance to department and local affiliates' regulatory staff as appropriate.
•Participates in development of a strategy to ensure development of talent; supports, mentors, and fosters talent development.
Additional Responsibilities
•Member of the Asia-Pacific leadership team to support extended group for projects and development.
•Responsible for the management of regional in-licensed registration submissions.
•Participates in the development of department processes and procedures; ensures defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities.
•Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment through networking with Industry Group(s).
•Provides support to Regional Head to develop metrics for the region.
Required Leadership Competencies (J&J Regulatory Affairs Competency Model)
•Applied Technical Knowledge (Expert): Leverages knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to develop compliant Regulatory strategies aligned with business objectives. Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements to obtain and maintain legal market status. Leverages scientific and technical knowledge to provide regulatory input to product lifecycle management and evaluate regulatory impact on products. Exhibits curiosity and passion to continuously learn about new scientific, technological, and Regulatory developments and explains Regulatory impact of risks to business partners.
•Business Acumen (Leading): Leverages knowledge of the sector, organization, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies. Assesses the impact of current regulatory requirements on the business to assist in developing innovative Regulatory strategies and/or innovative ways to execute them. Executes results-oriented Regulatory Affairs strategies aligned with organizational objectives. Determines the financial implications of Regulatory activities on business results using standard business metrics. Manages projects within timeline and budget requirements.
•Decision Making and Prioritization (Expert): Clearly defines and prioritizes decision criteria and considers benefits and risks of each decision and its immediate and future implications. Considers all available facts when situations are ambiguous to make the best possible decision. Manages multiple and changing priorities based on factors such as time constraints, urgency, and business need. Manages complex or ambiguous situations including integration of large amounts of changing, complex, or ambiguous information. Navigates a complex organizational structure to make effective, complex decisions and achieve strategic and/or project goals.
•External Focus (Leading): Leverages knowledge of the healthcare environment and external marketplace to inform Regulatory Affairs strategy and business decisions. Articulates the influence of social, economic and political factors on business and regulatory environment to business partners. Maintains understanding of the global Regulatory and commercial environment, including Regulatory challenges, competitor products, strategies, and market segmentation to accurately identify trends and opportunities. Leverages understanding of cultural differences to collaborate with stakeholders in other regions and countries.
•Leading and Influencing (Leading): Leverages understanding of others' motivations, needs, and concerns to establish trust and credibility and influence others. Shapes the Regulatory environment by influencing external stakeholders within local and/or regional regulatory agencies, industry groups, standards committees, and/or political/government agencies. Demonstrates conviction, proactivity and persistence when influencing internal and external stakeholders with or without direct authority or formalized structure. Creates compelling negotiating positions that build support and consensus among key stakeholders. Leverages internal and external networks to enhance collaboration, information sharing, and form strategic partnerships.
•Persuasive Communication (Expert): Delivers and creates tailored communications and presentations that educate and mobilize critical stakeholders and translates complex information into key facts and rational arguments that are influential, meaningful, and actionable. Fully engages others by asking incisive and thought-provoking questions, always ensuring mutual understanding. Develops written technical communications that are influential, meaningful, and tailored to the audience and business need, including translating complex or technical information into simplified explanations to promote understanding.
Required Technical Competencies & Knowledge
Regulatory Strategy
•Good understanding of the pharmaceutical industry.
•Detailed knowledge of local laws, regulations and guidance in the region related to the full drug life cycle.
•Understanding of how laws, regulations and guidance apply to specific projects; ability to interpret and understand them in the scientific and commercial context.
•Good understanding of and experience in drug development and/or marketed products.
•Ability to anticipate and influence regulatory developments in the region and assess business impact.
•Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.
•Awareness of pricing and reimbursement issues in AP.
•Understanding of how supply chain decisions impact registrations in AP.
HA and Operating Company Interactions
•Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome.
•Ability to work with and influence HA actions and outcomes.
•Project-related knowledge of commercial/medical business needs.
•Broad understanding of scientific data (CMC, clinical and non-clinical).
Regulatory Input into Other Functions
•Comprehensive understanding of the needs of regional business partners.
Submissions
•Detailed knowledge of laws, regulations, and guidance as they apply to submissions in the region.
•Knowledge of dossier components and submissions needed, how to obtain regional components and how long it takes to gather them. Understanding of documentation requirements.
•Ability to analyze reports to determine whether they meet regulatory requirements and are consistent with the regulatory strategy.
Labeling
•Knowledge of local labeling requirements.
•Ability to critically review labeling development/revisions and assess impact on relevant countries.
•Knowledge of the competitive landscape and how other companies deal with similar labeling issues.
•Experience in labeling negotiations with health authorities.
Resource Planning and Management
•Understanding of resources, time, expertise, etc. required to complete projects.
•Mentoring skills.
•Line management skills.
Decision-Making and Problem-Solving
•Must make proposals and negotiate on prioritization and trade-offs at a project level.
•Provides input to department strategic objectives, goals and performance measures.
•Independence in decision-making regarding regional strategies with supervisor approval.
•Defines operational priorities and tactics. Resolves conflicts in priorities in consultation with supervisor, liaison team leader, business partners and internal customers.
•Presents issues and solutions to senior management in the region and Health Authorities.
•Determines risk-management strategies for projects.
•Makes informed decisions by soliciting input from others where needed.
•Makes 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.
Independence/Autonomy
Operates independently in a complex environment. Independent in daily activities, with very limited managerial oversight. Sets long-term work priorities for self in consultation with supervisor and regulatory liaison team leader. Makes determination of routine work issues.
Reporting Relationships
Reports to Senior Director, Regional Regulatory Immunology Head. Will have direct line supervisory responsibility.
Working Relationships/Interfaces (Internal)
1.Within Global Regulatory Affairs: including GRL, and GRT members, TASLT and CDT, C-ROSS MS — as needed by project activities to establish project objectives and strategies and ensure knowledge sharing.
2.Local Regulatory staff, as needed by project activities to develop and evaluate drug project strategies and objectives and ensure knowledge sharing to enhance product development and registration activities.
3.Regional Integrated Value Team (IVT) and Cross-Functional Team (CFT) which includes Commercial, Market Access, Supply Chain, Medical Affairs, GCO, Communication, and other Regional Teams as needed for projects.
Knowledge, Education, Experience, Communication Skill Requirements
•Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline.
•Minimum of 10 years of relevant pharmaceutical industry experience, including at least 5 years of regulatory experience.
•Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements. Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and/or Registration dossiers).
•Demonstrated leadership and contribution to drug development strategies.
•Demonstrated ability to handle multiple projects.
•Demonstrated organizational skills.
•Ability to communicate to senior level management.
•Working knowledge of regulations.
•Experience in HA interactions.
•Experience specifically in the region is a mandatory requirement.
•Excellent verbal and written communication skills – proficiency in written and oral English.
•Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
•Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as ability to work in a matrix environment, required.
•Proactive team player, able to take charge and follow through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
•Proficient use of technology including AI and MS Office.
Working Conditions/Travel Requirements
•Position is located in the Asia Pacific region. Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones.
•Regional business travel (20-30%) is required.
Preferred Skills
Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Tactical Planning.
