Job: Regulatory Affairs Manager Job, Manila in Manila, National Capital Region

Regulatory Affairs Manager-00000T3V
Description
Role Description
The RA Manager applies professional principles, practices, and techniques to manage new product launch projects and product life cycle control renewal and change schedule and performance risks to ensure satisfied customers, regulatory compliance and smooth shipment custom clearance. This role has responsibility for all assigned projects and manages scope definition, planning and monitoring.
As an individual contributor; the function of the RA Manager is to combine knowledge of regulatory and business issues to enable products that are distributed to meet required legislation. This role has department and cross country level influence and provides input on changing regulations and guidance; interface with outside regulatory agencies and trade associations and provide management with regulatory metrics/information.
RA Manager Duties & Responsibilities
- Work collaboratively with supply chain and quality teams to maintain thorough knowledge of system/process capabilities, manage product data registration database and to ensure that all communications between stakeholders are precise.
- Thoroughly understand and communicate stakeholder requirements to appropriate team members, and manage all requirements accordingly to realize each for the stakeholder.
- Establish clear project tasks, ensure that team members have the tools needed, and provide timely feedback.
- Coordinate and facilitate delivery of project objectives.
- Track progress and review NPI tasks to make certain deadlines are met appropriately.
- Assess registration issues and identify solutions to meet productivity, quality and customer goals.
- Proactively communicate license status, issues & risks to management
- Conduct regular status meetings with all stakeholders, keeping the stakeholder’s needs and requirements continuously in view.
- Other duties may be assigned.
Implementation Duties & Responsibilities
- Define & maintain all implementation processes, manage implementation lifecycle; coordinate documentation when needed.
- Arrange training and align training with department goals.
- Troubleshoot technical issues when the need arises, and escalating appropriately as needed.
- Maintain timelines and target dates in NPI project metrics.
- Facilitate productivity by ensuring that the team has organized information to succeed.
- Find and work to remove development and project roadblocks; motivates the team and keep them excited to move forward; protects the team from outside distractions.
Qualifications
REQUIREMENTS
Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time; Manages project team activities.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Education
- Minimum bachelor's degree or equivalent in Pharmacy or Life Sciences or health-related discipline.
- Minimum 5 years of relevant health care industry experience, including at least 3 years of regulatory affairs experience in international regulatory affairs organization.
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson (Philippines) Inc. (8385)
Job Function: Regulatory Affairssucce468f5
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