Job Ref. ID:
UNITED ARAB EMIRATES
UAE (RAK head office)
Regulatory Affairs Manager
Full Time Employment (Un-limited Contract)
Regulatory Affairs Managers are responsible for ensuring that their organization is adhering to applicable regulations. Regulatory affairs managers help develop strategies to ensure regulation compliance. They also make sure that necessary documentation is completed and submitted
Manage activities such as audits, regulatory agency inspections, or product recalls. Responsible to participate in the development or implementation of clinical trial protocols.
Key responsibilities & Accountability:
• Review current processes to identify issues, design and conduct analyses, synthesize conclusions into recommendations, and help to implement required changes to bring best practices of the Industry
• Maintains current knowledge of relevant regulations, including local, regional and international regulatory guidelines.
• Develops regulatory strategies and implementation plans for the preparation and submission of new products registration including in-house and outsourced products in all operational markets.
• Collaborates with different departments in the company such as R&D, QA, QC, Tender, Finance, and Marketing to collect necessary regulatory documents.
• Planning and implementing of all renewals and related activities in all operational markets.
• Creates and maintains the corporate database of all dossiers submitted and approved for future reference.
• Presents RA expertise and supports the business development in both internal and external projects.
• Organises task forces to address special RA and business needs.
• Coordinates with regulatory agents in different countries, distributors in order to fulfill the registration requirements
• Ensures the timely response to various queries raised by different HA
• Contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Regulatory strategies
• Establishes regulatory priorities and allocate resources and workloads.
• Training and coaching the RA team with respect to regulatory technical skills
• Manage activities like audits and HA inspections.
• Provides regulatory guidance to different departments regarding the design, development, evaluation, and marketing the products.
• Monitors and ensures compliance with local and regional regulations and standards.
• Review all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness and compliance with regulatory standards.
• Must possess strong understanding of regulatory and reporting requirements for the organization
• Recognize the need of integration and streamlining for improving of internal and external reporting.
• Build professional relationships with clients, management and team members to ensure delivery of proposed solutions, support for development of business possibilities and for personal development
• Ability to strategize, lead and influence matrix teams in the design and execution of various Regulatory Dashboards including utilization of resources (FTE and budget).
• Must showcase the ability in relevant soft skills including change management, continuous improvement, conflict resolution and consensus building activities
• Experience working with senior decision makers
• Contribute to high productivity and motivation of working team with the use of communication skills and cooperation; reach and realize project aims and outputs
• Stay up to date on job knowledge by participating in educational opportunities, attending conferences and workshops, reading professional publications, maintaining a personal network and joining professional community organizations.
• Deliver proactive and effective communication related to improvement initiatives.
• Collaborate with multiple teams to determine their challenges in hand and prioritize solutions
• Maintain and promote a teamwork environment with effective and clear communication amongst colleagues
• A performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business.
• Subject matter Expert and must be very strong on Technical Competence
• Advanced Excel skills
• Must be highly result oriented with strong sense of accountability & ownership,
• Excellent communication, interpersonal and presentation skill.
• Having a Strategic and Analytical mind with ability to think diversely and understand the big picture.
• You have excellent Technical Knowledge and Strategic Planning skills for diversified Regulatory Project Management experience coupled with strong influencing skills
• Excellent time management, communications, public speaking, and presentation skills with multitask and strong negotiation skill
• RA Manager must have strong leadership skills for managing at least several data point and stakeholders
• You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.
M Pharma Degree with experience in the technical side of Regulatory and Quality in pharmaceuticals industry
• Minimum 6-8 years of Experience
• Strong proven experience with high business acumen in analysing business processes and defining apt models.
• Must be experienced in managing complex and sensitive operational challenges.
• Experience working with matrixed, geographically distributed and functionally diverse work groups is preferred.
• Adapt at identifying issues, driving to root cause and able to negotiate solutions & solve problems
• Competent use of statistics related to business improvement metrics and Dashboards.
• Proven ability to build strong partnerships with the business, Commercials, Operations, Science, Quality, Finance, Production and other key stakeholders is required.
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