The job holder will be responsible for performing activities in drug
regulatory affairs, he/ she will:
Core Accountabilities
Regulatory:
* Ensure timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities for assigned products
* Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations
* Ensure timely, accurate and compliant labelling translations and artwork preparation for assigned products
* Recommend changes for labelling, manufacturing, and marketing for regulatory compliance
* Monitor and improve tracking / control systems
* Foster an environment/culture of learning and sharing of best practices within the team
* Develop, maintain, and support cleaning of products databases
* Maintain and update regulatory files and records as required; ensure appropriate archiving of all relevant documentation to be in line with applicable internal company standards. Also, support process improvements and implementation of best practices especially for archiving and other technical systems
* Follow up and answer MOH queries in timely manner till final approvals are granted and shared with all interested parties
Good Regulatory Practices (GRP):
* Maintain valid and updated Local SOPs
* Complete the Annual GRP checklist
* Ensure regulatory team gets the needed trainings for new procedures and are well updated on the current procedures
* Keep job descriptions and training matrix updated
* Continuously evaluate GRP processes to identify points of simplification, optimization and needed improvements including current controls and metrics relevant to the company, to make this process increasingly effective
Qualifications / Experience needed:
* Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science
* Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment
* Knowledge of drug development practice, rules, regulations and guidelines
* Networking internally and externally to learn in advance about new trends or changes impacting the Regulatory, Medical and overall Business strategy
* Advanced degree is a "Plus"
* Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines is desirable
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.
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