JOB TITLE Senior Regulatory Affairs Manager
ABOUT ASTRAZENECA
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. 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 submissions
This position covers Gulf markets (UAE, Kuwait, Oman, Qatar and Bahrain).
May be responsible for specific therapeutic area/-s and/or specific regulatory project/-s, and represent the key point of contact for a specific market/-s on full AZ portfolio in scope of the assigned therapeutic area.
What you’ll do
RA 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 Prioritizes 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.
Only applications based in UAE will be considered.
Essential for the role
Completed higher education (pharmaceuticals, medicine, biotechnology), potential & willingness for people development & management Min. 7-9 years 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 license maintenance, or experience at a health authority, min 5 years 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
Desirable for the role
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
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.
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