Manager, Regulatory Affairs

Worldwide Clinical TrialsIndia only

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Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials , and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

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Manager, Regulatory Affairs at Worldwide Clinical Trials · ApplyPick

SUMMARY: **The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.**RESPONSIBILITIES:*_Tasks may include but are not limited to:_Provide expert regulatory advice and contribute to regulatory project workEnsure accurate compilation, management and tracking of submissionsParticipate in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defense meetings to meet business needsDevelop department work practices and other company initiativesLiaise with the Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis,Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regionsStay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence databaseContribute towards the preparation of technical documentation such as IMPDs and IBs which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissionsReview and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirementsEffectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staffComply with SOPs, ICH GCP and national regulations as applicableFoster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiersProvide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staffDeputised for the Regulatory Affairs Director as required Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. *OTHER SKILLS AND ABILITIES*: Clearly, proven leadership and organizational management skills are essential attributesStrong planning, strategizing, managing, monitoring, scheduling, and critiquing skillsExcellent written and verbal communication skills to clearly and concisely present informationStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentExcellent ability to handle multiple tasks in a fast-paced and constantly changing environmentAbility to exercise sound judgment and make decisions independentlyExcellent self-motivation skillsProficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPointExpert knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)Expert knowledge of drug development *REQUIREMENTS*: Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experiencePrevious experience within the pharmaceutical/CRO industry Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. We love knowing that someone is going to have a better life because of the work we do.

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