Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the AstraZeneca products in GCC markets. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Implements strategies to improve quality and efficiency of submissions and licenses maintenance.

Ensures Regulatory compliance aspects throughout product lifecycle to ensure delivery of high quality products to the market, keeping AZRA Systems and portals updated in ling with GRP compliance aspect.

Leads pricing strategy for the brands and ensures alignment within cross functional teams, in terms of pricing agreement/ alignment decisions involving relevant GCC commercial and operations teams.

Typical Accountabilities:

Regulatory Affairs:

• Effective lobbying and influencing with regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in GCC to support and advise relevant functions
• Provide strategic regulatory advice support for product developments
• Represent AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Provide expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority Regulatory requirements
• Lead and provide regulatory expertise on GCC regulatory submissions and health authority briefings
• Ensure adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensure all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps.
• Make a significant contribution to product marketing company strategy
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Identify global budget priorities, taking careful note of portfolio growth and business needs
• Identify potential complex regulatory risks to global and regional operational plans, and propose options to mitigate risks
• Implement excellent communication within regulatory and other functions in Gulf (eg. ongoing submissions, the short-term plans and long-term plans)
• Communicate all the regulatory updates to the relevant departments to plan for the new products launches accordingly and to assess any impact to the existing products and create mitigation strategies accordingly (if necessary).
• Ensure timely & effective New Drug Application NDA submission and line extensions, License Maintenance and Documentation
• Any item to manage distributors from regulatory perspective? It’s important that we lead the regulatory function at distributor who works on behalf of us instead of getting directions from distributor.

Pricing alignment:

• Lead and contribute to developing pricing strategies for all products registered/under registration plans in GCC
• Lead pricing environment knowledge development through ‘Horizon scanning’ for changes in the local market regulations & external environment; drawing conclusions for the likely impact on AstraZeneca’s brands portfolio, creating and developing future/mitigation scenarios for the pricing / reimbursement environment; involving Pharmacoeconomics modelling in collaboration with Market Access
• Drive and lead the provision of environment information to colleagues working in Commercial & Marketing teams for their use within the brand teams and in forecasting 
• Evaluates changing marketplace and proactively makes recommendations on pricing strategies as related to managed care, reimbursement environment, federal and state regulations
• Monitors environment and practices for shifts in trends or behaviors, interprets likely impact and suggests appropriate actions
• Develops deep understanding of competitive market conditions that affect pricing for individual brands and overall industry

Leadership and team management:

• Set ambitious goals for the employees of the Regulatory departments in Gulf & Saudi, and ensure their cooperation with other departments of the company to achieve better results
• Identify strengths and development needs, motivate and train subordinates to improve their performance effectiveness and develop functional and leadership competencies.
• Conduct annual goal setting and performance and development check-ins, feedforward and coaching with subordinates according to corporate standards
• Implement control measures to compare the actual results of the work performed with the goals and take appropriate action in case of deviations from the plan.
• Analyze and resolve possible difficulties for the effective work of the team. Create challenges and inspire team to increase productivity.
• Has personal responsibility for creating a culture of courageous and inclusive leadership, innovations and collaboration, proactive approach

Financial Planning

• Manage Regulatory Affairs budget & reporting team variable costs
• Ensure work & planning of the team is based on clear economic rationale and key activities are carried out within the budget
• Manage resources to optimize investment and maximize returns
• Provide regular forecasts for the budget and projected expenses at the end of the year, re-evaluating the budget in accordance with priorities, markets conditions and a profound understanding of the products on the market.

Stakeholders management

• Build relationships with key internal / external clients, closely cooperating with GCC business managers and country directors, local country regulators.
• Report on the status of implementation of the tactical plan to internal customers.
• Builds and develops optimum global working relationships and processes with other key stakeholders in AstraZeneca Regulatory Affairs and Pricing to gain efficiencies
• Ensures effective collaboration across the GCC Regulatory Affairs interface enabling rapid and effective submissions, approvals for regulatory and pricing and other product maintenance activities

Corporate responsibility:

• Maintain highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies
• Ensure that all conducted activities are done in accordance with local legislation and corporate standards.
• Timely report (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.

Education, Qualifications, Skills and Experience:

Essential:

• Medical/ Pharmacy/ life sciences degree
• >10 yrs of experience in Regulatory and/or pharmaceutical environment with experience of regulatory drug development, manufacture, commercialisation and pricing
• >3 years of successful people management
• Solid understanding  of Pharmacoeconomics modelling
• Proven successful leadership and project management experience
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
• Scientific & strategic mindset
• Strong influence & negotiation skills
• Regulatory & Pricing Strategy Development
• Regulatory Submissions & Approval Management
• Regulatory & Pricing Environment Insight
• Pharmacovigilance Excellence
• Patient Benefit / Risk Assessment
• Quality Management
• Business Relationship Management
• Change Enablement

Desirable

• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Significant Regulatory Experience across global projects and regions
• Strong commercial awareness
• Problem solving skills
• Develops collaborative working relationships
• Proactively Innovate and Adapt
• Process Management & Continuous Improvement
• Supplier/Partnership Management
• Audits & Inspections Knowledge

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.