Regulatory Affairs Manager

Regulatory Affairs Manager - KSA

AstraZeneca 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.

Role Summary

Responsible for preparation, publication, quality control, and delivery of all submissions. Works on complex technical problems. Acts as regulatory advisor to management and customers on technical research studies and applications. Implements strategies to improve quality and efficiency of submissions. This position covers Saudi Arabia, may be responsible primarily for specific therapeutic area, and represents the key point of contact for the Saudi market full AZ portfolio.

Responsibilities

• Lead the Submission Management Group and/or cross functional submission teams for complex, worldwide regulatory applications, ensuring they comply with AstraZeneca's submission ready standards.
• Proactively solicit information from the Global Regulatory Lead, plan and monitor execution of submissions related activities.
• Provide expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority regulatory requirements.
• Continuously collaborate with and support AstraZeneca customers in all regions to gain an understanding of business processes and challenges relative to effective electronic working.
• Ensure business support needs and information systems demands are identified and addressed.
• Prioritise project related operational and strategic activities for deployed staff.
• Ensure regulatory business needs are incorporated within AstraZeneca's regulatory systems by being involved in developing requirements, processes and standards.
• Lead and/or participate in special critical projects (e.g., regulatory strategy).
• Provide 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.
• Develop and maintain strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Representatives, etc.
• Manage a section of a skill group such as CMC or regulatory affairs project management; responsible for skill development, performance management, and resource allocation.
• Provide supervision, timely and constructive feedback, and coaching to AZ colleagues, esp. more junior regulatory staff.
• Identify potential complex regulatory risks to the global and regional operational plans and propose options to mitigate risks.
• Act 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.
• Work as a partner within relevant product and project teams, providing regulatory intelligence and advice, and strategic input, as appropriate.
• Implement strategies to improve quality and efficiency of submissions.
• Lead or manage 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.
• Review and approve required reports and supplemental submissions, advertising and promotional items for regulatory compliance, labeling to ensure compliance.
• Ensure a system is in place to manage access to information requests.
• Develop, implement and manage SOPs and systems to track and manage product associated events.
• Provide regulatory input for follow up to inspections and audits to minimize potential for findings of non compliance.
• Develop 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.
• Conduct additional tasks as assigned by Line Manager per business need. Normally expected to conduct basic people management responsibilities: coaching, developing others, supervising, managing and guiding regulatory professionals in the absence of Line Manager.

Business Partner for County RA Agenda

• Regulatory contact person for the Head and related BUDs.
• Contact person for any official interaction with authorities.
• Responsible for updating systems and global teams on any update on guidelines or important communications or decrees.
• Align between therapy areas regulatory affairs managers on all outstanding regulatory activities and keep tracking on it.

Corporate Responsibilities

• 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 you become aware of; changes in status of your conflict of interest.

Business Relationship Management

• Develop strategic and collaborative relationships with external stakeholders and work with them to achieve joint objectives with AZ.
• Maintain 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 advise internal stakeholders of all relevant matters.
• Address the engagement needs of key stakeholders through tailored interactions.
• Collect and analyse relevant data, using appropriate methodologies, and offer practical solutions and advice which meet stakeholders' requirements.

Essential Qualifications

• Completed higher education (pharmaceuticals, medicine, biotechnology), potential & willingness for people development & management.
• Min. 5 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.

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.