Regulatory Affairs Associate II
3 weeks ago
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
Compiling and reviewing of the Annual Report and ensuring it is submitted prior to the commitment date (at minimum no later than the due date). Assessing, reviewing and approving the change controls initiate by manufacturing sites. Compilation and submission of post approval supplements (CBE 0, CBE 30, PAS) in US. Coordinating the retrieval of supporting documentation in accordance with the Annual Report schedule. Retaining all supporting documentation as required in completing an Annual Report. Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Decision Making:
Own authority
Organisation of own workload to meet set departmental and Company targets. To support the execution of the department’s work plan.Referred: Understanding the need to refer issues and decisions that are outside of the individual’s experience and competence to line manager.
Your experience and qualifications
Qualification:
Degree in science/life science/pharmacy or equivalent qualification(s)
Experience:
Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered. Desirable to have experience with preparation and compilation of Annual reports. Handling of change controls and process. Experience and through knowledge in assessing and filing of US post approval supplements.Knowledge:
Desirable to have knowledge of US regulatory applications. Understanding of processes and departments within a pharmaceutical company.
Skills
Excellent oral and written communication Ability to work under pressure and to tight time deadlines. Effective time and organization management Negotiation Initiative Analytical (Data and Documentation) Computer literacy Teamwork and collaboration Attention to detail. Planning and Organization
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