Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Asia Pacific Regional Management Center (RMC) Compliance Manager
• Single point of contact for Global (CMC RA and Labeling CoE) to address prioritization and escalation in case of potentiation compliance risks
• Collaborate pro-actively with Global, RMC team and Local operating Company for priority changes or potential compliance risk
• Supports the onboarding of new RMC and LOC staff in the RMC processes
• Reference country designation tracking and monitoring
• AP submission dependency tracking and monitoring
• Project completion and archiving
• Overall responsibility for compliance in AP
• SPS/InSight and Trackwise compliance – escalations
• Responsible for compilation and monitoring of LIDs
• SPOC for all LOC Submission Specialists (RMC) related queries in audits
• Management of RMC Systems Specialists
• Collect input from involved Global, Regional, Local regulatory teams
• Identifies gaps / areas for clarification (with CMC & Global Labeling, LOC, RMC team members)
• Take action to close these gaps in liaison with Global, Regional, Local and RMC regulatory teams
• Create resource report (overview) for RMC
• Collaborate with RMC Submission Professionals and RMC Liaisons on dossiers in scope, in case of priority changes or potential compliance risks
• Ensure compliance with submission and approval deadlines
REQUIRED LEADERSHIP COMPETENCIES (J&J REGULATORY AFFAIRS COMPENTENCY MODEL):
• Business acumen (Applying): 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 the development of innovative Regulatory strategies and/or innovative ways to execute them. Executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Manages projects within timeline requirements.
• Decision Making & Priority (Leading): Clearly defines and prioritizes decision criteria and considers benefits and risks of each decision and its immediate and future implications. Considers all of the available facts when situations are ambiguous in order 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.
• Leading & Influencing (Applying): Leverages an understanding of others’ motivations, needs, and concerns to establish trust and credibility and influence others. 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 networks to enhance collaboration, information sharing, and form strategic partnerships.
• Persuasive Communication (Leading): 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
• Understanding of the pharmaceutical industry and experience in drug development and/or marketed products.
• Analytical skills and technical RA knowledge (ability to assess impact of CMC variation or Label change on current situation).
• Detail-orientation combined with big picture orientation.
• Ability to quickly acquire local knowledge and shift between local and regional situations+ learning agility.
• Understanding of resources, time, expertise, etc. required to complete LCM-projects.
• Understanding and ability to lead process-improvement and –optimization projects.
• Understanding of planning-and tracking system to ensure oversight and compliance.
• Project management: get things done, drive execution, and collaborate in virtual teams.
• Communication skills and cultural sensitivity in working with stakeholders across countries
• Proficient in English (incl. technical RA English).
• Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers.
• Solid RA submission knowledge; high level of understanding of regulations, and guidance as they apply to submissions in the region.
• Knowledge of what is needed for submissions, how to obtain regional components and understanding of timelines. Understanding of documentation requirements.
Interactions with Local Operations Companies:
• Strong negotiating skills to ensure agreement with LOCs, on planning and expected services.
• Strong management skills to ensure that the agreed services to LOCs are delivered.
• Project-related knowledge of commercial/medical business needs.
Interactions with global and regional GRA-teams and other Functions:
• SPOC for planning, prioritization, progress reporting and escalation
• Close collaboration with peers in the other regions
• Comprehensive understanding of the needs of global and regional business partners.
• Good negotiating skills to ensure agreement with global and regional teams on planning and expected services.
• Understanding of compliance requirements and ability to influence outcomes.
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Decision Making and Problem Solving:
• Operates in a competitive, complex, and rapidly changing environment.
• Must make proposals and negotiate on prioritization and trade-offs on a project and resource level.
• Provides input to department strategic objectives, goals and performance measures.
• Independence on decision-making regarding regional strategies with supervisor approval.
• Identify and act on process optimization opportunities.
• Defines operational priorities and tactics.
• Resolves conflicts in priorities in consultation with supervisor and internal customers.
• Makes informed decisions by soliciting input from others where needed.
• Makes complex decisions in situations with multiple, ambiguous objectives and constraints.
• Operates independently in a complex environment.
• Independent in daily activities, with limited managerial oversight.
• Sets long-term work priorities for self in consultation with RMC head.
• RMC Head, RMC Planning & Operations Lead, RMC Liaisons, and RMC Systems Specialists
• Regulatory Head and Local Regulatory staff, as needed by project activities to ensure compliance
• LOC Submission Specialists
• Minimum Bachelors’ degree in pharmacy, life sciences or equivalent field
• Minimum of 5 years of project management / resource planning experience
• Minimum of 3 years of regulatory experience
• Demonstrated organizational skills, complex project management skills, as well as experience working in a matrix organization
• Knowledge of local and regional regulations/legislation (preferred)
• Experience in working with limited supervision and able to make independent decisions
• Excellent verbal and written communication skills – proficiency in written and oral English
• Ability to communicate to senior level management
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment
• 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 planning, compliance and resource systems
• Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones
• Occasional international travel (3-5x/year) may be required
Experience : 3-5 Years
Qualification : B.Sc / B.Pharm
Location : Singapore, Singapore; Malaysia; Japan; Thailand; Vietnam; Australia; India; New Zealand; Philippines; South Korea; China
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Compliance
End Date : 30th August, 2019
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