Regulatory Affairs Director GCC

Duties and Responsibilities :
Strategic and tactical input in development, post-approval and Life cycle management
• Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
• Develop and implement country objectives based on Janssen business priorities, and global regulatory strategies and plans
• Align with Regional organization on accountabilities and interfaces to create the country-specific regulatory strategy for registering new products and existing products
• Provide leadership and manage relationships through extensive interdependent partnering, benchmarking, leveraging of best practices, and forming strategic alliances with cross functional partners to drive key business goals and objectives
• Coordinate with: other Regional RA leaders to develop and harmonize efficient processes and ways of working to ensure :
• efficient workflow and transparency
• creation of technical documentation required to register new products in markets
• developing and aligning project priorities across multiple business units through collaboration with internal RA partners and other functional business partners
• to ensure that in partnership with the EMEA RA and Regional leadership will develop plans and coordinate regulatory submissions to support product registrations and maintenance
• Provides support for Supply Chain and Compliance initiatives that impact the portfolio of marketed products (e.g., cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements)
• Accountable and responsible to plan and direct resources and activities of regulatory group to deliver business imperatives , maintain product regulatory compliance and sustain market access
• Accountable for Regulatory Compliance in the region / instils a mindset of Regulatory compliance within the team
• Drives effective business strategies to ensure regulatory programs and projects are standardized to obtain earliest possible approvals.
• Provides measurable input into the development and implementation of Regulatory Affairs processes, standards, or plans in support of the organisation s strategies.
• Drives a culture of Business Process Excellence
• Provides overall management of the Regulatory staff development and budget to support business objectives.
• Establishes learning initiatives and training of country personnel on current and emerging regulatory and related requirements
• Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures
• Serve and primary liaison to Region and be an active participant on the Regional RA leadership team
• Determine resource requirements for assigned projects and anticipate needs for major filings
• Drive understanding of central and national regulatory requirements
• Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
• Ensure appropriate implementation of scientific advice/Regulatory Agency comments into development and life-cycle management plan
Liaison with Regulatory Agencies and Local Operating Companies
• Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
• Act as primary contact with EM and EMEA
• Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
• Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies and scientific advices.
• Ensure issues raised by Regulatory Agencies are promptly and adequately addressed
• Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies
Clinical Trial Applications (CTA)
• Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
Marketing Authorization Application (MAA)
• Provide regulatory support throughout registration process and life-cycle management
• Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
• Ensure country-specific submission packages are made available to the LOCs in EMEA reg
Talent and Development
• Ensure training and provide leadership to the team to ensure talent development and experience sharing within the cluster and wider region
• Ensure a pipeline of succession planning within the GCC cluster
• Ensures team diversity and creates a culture of innovation in line with Johnson and Johnson Credo values.
• Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints;
• Serve as the Regulatory representative on specific multi-discipline teams;
• Keep abreast of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidance and requirements related to those areas.
Qualifications
Required Qualifications
• A minimum of a University degree - medical or paramedical (pharmacy, biology, veterinary etc.)
• Breadth of regulatory experience in drug development and market access (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas) - 10+ years of relevant industry experience.

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