Johnson & Johnson Careers

Regulatory Planning & Compliance Manager

Singapore, Singapore
Regulatory Compliance


Job Description

Requisition ID: 1700166812W

Johnson & Johnson is the world’s most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day.  Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world’s most pressing health issues.
 
POSITION SUMMARY:
The Regional Management Center (RMC) is a new regional organization to handle the majority of LOC activities led by senior regional regulatory staff, where they handle tactical LCM processes (CMC Variations and Labeling Changes) in the region. The center will be embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOC’s and regional and global departments.
 
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization). In order to enable the RMC to achieve its deliverables in terms of quality, compliance and efficiency, an integrated planning is key, in which global, regional and local submission plans are consolidated and which will translate in optimal resource allocation across clusters and countries. 
 
The Regulatory Planning & Compliance Manager drives integrated planning to enable the RMC to achieve deliverables with optimal resourcing. He or she is responsible for the maintenance and compliance of the RMC planning tool and integrating submission planning from global, regional, and local RA. The incumbent will be accountable to engage stakeholders throughout the process to define best fit planning and assign submissions to RMC staff and monitor progress. In this role the Regulatory Planning & Compliance Manager will be the single point of contact (SPOC) for Global teams on planning, prioritization, escalation, in which he/she closely aligns with the RMC head. Together with the RMC team, he or she will seek continuous improvement of the processes and propositions.
 
The Asia Pacific RMC Operations Manager reports to the Asia Pacific RMC Head.
 
KEY RESPONSIBILITIES:
  • Single Point of Contact (SPOC) for Global CMC and Labeling CoE to disseminate variation updates for RMC and Local operating Company
  • Manage milestone planning for Local operating Company & RMC team
  • Optimize and maintain planning/managing tool and provide oversight to Local operating Company
  • Collaborate pro-actively with Global, RMC team and Local operating Company for priority changes or potential compliance risk
  • Supports in the set-up of the RMC and onboarding of the LOCs
  • Optimize and maintain the RMC planning tool
  • Embeds the planning process in the region and drives continuous improvement
  • Collect input from involved Global, Regional, Local regulatory teams
  • Drive integrated planning process by engaging RA stakeholders to ensure insight on all inputs
  • 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
  • Monitor resource planning and pro-actively act on potential conflicts
  • Monitor milestone planning and report to RMC head, Local, Regional, and Global regulatory teams
  • Create resource report (overview) for RMC
  • Single point of contact for Global (CMC RA and Labeling CoE) to align on planning, address prioritization and escalation in case of potentiation compliance risks
  • Collaborate with RMC Professionals and dossier leads 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.
 
WORKING RELATIONSHIPS/INTERFACES:
Within RMC:
•With RMC Specialists on specific tasks (Data administrator, Label Coordinator, Artwork specialist)
•With RMC Professionals in collaborating on cross-cluster submission)
 
With LOC:
•Regulatory Head and Local Regulatory staff, as needed by project activities to define and evaluate integrated planning
 
Within Global Regulatory Affairs:
Global and Regional departments (RSI, RSMO, CMC, Labeling CoE and regional TA-members), as needed to define and evaluate integrated planning
REQUIRED TECHNICAL COMPETENCIES & KNOWLEDGE 
Regulatory Strategy:
  • 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.
Planning:
  • 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.
Drive execution:
  • 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.
Submissions:
  • 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.
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.
Independence/Autonomy:
  • 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.

Qualifications
 

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

  • 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

LOCATION

  • The position is located in the local region.  For AP, location in Singapore is preferred but not required.
  • 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
     

TRAVEL REQUIRED
This role requires less than 10% of the time

 

Please note that there is no relocation assistance provision for this position. The selected candidate can continue to be based in his or her home country.

 


 


Primary Location
Singapore-Singapore-Singapore
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Regulatory Compliance
Requisition ID
1700166812W