Manager, Start-up and Regulatory Affairs

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for completing study start-up and regulatory deliverables based on an established regulatory SSU RA management plan. Requirements Degree in Chemistry or Life Sciences, Nursing or equivalent experience Minimum 3 years within pharmaceutical or CRO industry or Regulatory body, of which at least 2 years in a leading/project management role Proven ability to successfully manage global projects Expert knowledge of ICH GCP and/or GVP and comprehensive understanding of relevant legislation/ regulatory requirements globally Excellent organizational and management skills Excellent planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills Exceptional written and verbal communication skills to clearly and concisely present information Outstanding interpersonal skills in a fast-paced, deadline oriented, and changing environment Remarkable attention to detail Excellent ability to manage multiple tasks, set priorities, and adapt to changing work assignments Ability to exercise sound judgment and make decisions independently Excellent self-motivation and motivation skills Proficiency in English, both written and verbal Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet. Benefits Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Competitive salary Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth Multicultural environment, English as a company language Strong emphasis on personal and professional growth Originally posted on Himalayas