Regulatory Affairs Senior Manager ? Gulf

Job Description

JOB TITLE Sr. Regulatory Affairs Manager - DubaiABOUT ASTRAZENECAAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world?s most serious diseases. But we?re more than one of the world?s leading pharmaceutical companies.ROLE SUMMARY Responsible for preparation, publication, quality control, and delivery of all submissions. Works on complex technical problems. Acts as regulatory advisor to mgt and customers on technical research studies and applications.Implements strategies to improve quality and efficiency of submissionsThis position covers a single big country (eg. Saudi) or several medium-size markets (eg. UAE, Kuwait, Oman, Qatar, Bahrain, and Pakistan)May be responsible primarily for specific TA, and represent the key point of contact for a specific market/-s on full AZ portfolio.What you?ll doRA strategies for qualitative & efficient submissions:

• Leads Submission Management Group and/or cross-functional submission teams for complex, worldwide regulatory applications, ensuring they comply with AstraZeneca?s submission-ready standards
• Proactively solicits information from the Global Regulatory Lead, plans and monitors execution of submissions related activities
• Provides expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority Regulatory requirements
• Continuously collaborates with and supports AstraZeneca customers in all regions to gain an understanding of business processes and challenges relative to effective electronic working
• Ensures business support needs and Information Systems demands are identified and addressed
• Prioritises project-related operational and strategic activities for deployed staff
• Ensures Regulatory business needs are incorporated within AstraZeneca?s regulatory systems by being involved in developing requirements, processes and standards
• Leads and/or participates in special critical projects (e.g. Regulatory strategy)
• Provides knowledgeable, professional, and interactive representation on industry or internal forums to ensure AstraZeneca?s Regulatory interests and requirements are communicated and incorporated into key decisions
• Develops and maintains strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Reps., etc.
• Responsible for the management of a section of a skill group such as CMC, regulatory affairs project management, etc. Responsible for skill development, performance management, resource allocation.
• Provides supervision, timely & constructive feedback and coaching to AZ colleagues esp. more junior Regulatory staff
• Identifies potential complex regulatory risks to the global and regional operational plans, and propose options to mitigate risks.
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
• Acts as an expert resource to product development teams to resolve more complex regulatory issues and ensure the success of all elements of the regulatory process
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Implements strategies to improve quality and efficiency of submissions.
• Leads or manages projects or complex products through all stages of the regulatory process, while providing expert advice in specific regulatory areas.
• Manage processes and personnel involved with maintaining annual licenses, registrations, listings and patent information
• Ensure compliance with product post marketing requirements
• Reviews and approve required reports and supplemental submissions, advertising and promotional items for regulatory compliance. labelling to ensure compliance
• Ensures a system is in place to manage access to information requests
• Develops, implements and manages SOPs and systems to track and manage product- associated events
• Provides regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
• Develops a system to ensure product safety issues and product-associated events are reported to regulatory agencies
• Represent regulatory affairs in product recall and recall communication process
• Conducts additional tasks as assigned by Line Manager per business need. Normally expected to conduct basic people management responsibilities: coaching, developing others, supervising, managing & guiding regulatory professional in the absence of Line Manager

Business Partner for county RA agenda:

• Regulatory contact person for the country Director/Head.
• Country responsibility on having monthly meeting with our agents regulatory teams in country.
• Contact person for any official interaction with authorities.
• Responsible to update systems and global teams on any update on guidelines/or important communications or decrees.
• Aligning between therapy areas Regulatory Affairs managers and the local agent on all outstanding regulatory activities and keep tracking on it.

Corporate responsibility:

• Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies
• Ensures that all conducted activities are done in accordance with local legislation and corporate standards.

Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.Business relationship management

• Develops strategic and collaborative relationships with external stakeholders and works with them to achieve joint objectives with AZ.
• Maintains an up-to-date understanding of all developments & dynamics of the authorities & key institutions which may affect the organization?s operations and policies and proactively advises internal stakeholders of all relevant matters.
• Addresses the engagement needs of key stakeholders through tailored interactions.
• Collects and analyses relevant data, using appropriate methodologies, and offers practical solutions and advice which meet stakeholders requirements.

Conceptual Thinking

• Fits information into mental models and frameworks.
• Makes connections between facts and events that are not really obvious.
• Recognizes how one situation may be affected by another and thinks of the implications of actions on other tasks/projects.
• Relates different pieces of information and recognizes trends.
• Understands how own tasks relate to the wider framework.
• Compares present data and events with previously defined frameworks.

Strategic Thinking

• Associates information in order to analyze a situation.
• Takes a longer-term view and considers future needs.

Evaluation and analysis

• Identifies information sources
• Supports others with data collection and analysis

Business Awareness/ Acumen

• Applies knowledge of the organization?s products and services to the service offerings.
• Demonstrates a sound knowledge of the industry and commercial environment and uses knowledge of major competitors and markets when undertaking activities.
• Understands how business cases align with organizational strategy and identifies key benefits, costs, and risks and presents them in a format to enable decision making.
• Develops benefits tracking strategies for smaller projects, uses this to prioritize delivery and works with colleagues/suppliers in defining the intended benefits.
• Applies financial management principles to areas of responsibility.

Initiative

• Scan the external environment for new ideas and trends.
• Questions the way things are done and drive new and innovative ways to conduct activities & projects.
• Generates opportunities and ideas with stakeholders or authorities which enhance business performance.

Management Reporting

• Develops a coherent and understandable summary of business performance versus the target.
• Handles troubleshooting queries on management report data.
• Demonstrates working knowledge of industry standard benchmarks to enable external cross industry comparisons.
• Effectively analyses and interprets contradictory data, drawing out conclusions and recommendations that achieve desired business benefits.

Change Enablement

• Drives and leads development of the change approach for a project.
• Skillfully applies knowledge of change tools, and demonstrates ability to engage the right people, obtain resources and plan and drive change, recognizing that everyone is an agent for change.
• Manages others through change.
• Drives and leads implementation of change activities and projects within the function or business area.
• Supports change within their area of the business to achieve business goals taking processes, human response and the wider business context into account.
• Deals with change in a positive and constructive way, manages resistance and develops creative solutions to issues.
• Designs the change plan, manages communications and develops change leaders.

Stakeholder Management

• Lead the communication of key features, benefits and advantages of brands and portfolio.
• Clearly describes the key aspects of AZ products and the strategic and clinical importance they hold with respect to key claims and positioning.
• Has the skills to raise discussions & negotiation to highlight the brands benefits with stakeholders.

Strategic Product knowledge

• Develop and maintain relationships with important stakeholders in the key institutions within responsibility.
• Collect information on trends, priorities, needs and objectives of the stakeholders at the level of key institutions.
• Is able to communicate with stakeholders to ensure understanding of AZ strategy &/or value story & respond effectively to their concerns & needs.
• Develops and maintains relationships with key internal stakeholders.

Essential for the role

• Completed higher education (pharmaceuticals, medicine, biotechnology), potential & willingness for people development & management
• Min. 9 yrs working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and licence maintenance, or experience at a health authority, min 5 yrs in multinational company with solid performance contribution
• Solid knowledge of local and international regulatory standards, requirements and practices, understanding of business principles, logistics, finance, excellent communication skills, project and process management, problem solving skills, basic leadership skills, solid influence skills
• Experience managing resource requirements for pivotal projects
• Excellent negotiation skills
• Excellent global team working capabilities
• Knowledge of AstraZeneca business and processes
• Proven Project Management skills

Why AstraZeneca?At AstraZeneca we?re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There?s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We?re on an exciting journey to pioneer the future of healthcare.So, what?s next?

• Are you already imagining yourself joining our team? Good, because we can?t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it?s yours.

Where can I find out more?Our Social Media, Follow AstraZeneca onFollow AstraZeneca on FacebookFollow AstraZeneca on Instagram Date Posted14-Aug-2022Closing Date21-Aug-2022AstraZeneca 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.

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