Regulatory Affairs, Senior Specialist / Manager

Company Description

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

Ergomed is looking for a Regulatory Affairs professionals with in-depth experience in managing global complex clinical studies.

Opportunities are open to any geographical location; however, candidates will be required to possess excellent written and communication skills in English as well as good understanding of clinical trials environment / ICH GCP.

Main responsibilities for the role are :

• Assume leadership and functional representation for projects and / or deliverables of medium / high complexity ensuring effective and rapid coordination and management and execution of SSU / regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.

Develop strategy and manage set up activities (SSU RA Management Plan, procedures and core documents) ensuring compliance and consistency with department standards. Support team members in preparing project strategy, identifying issue and providing resolution.

Author / contribute towards the preparation and / or review of complex technical / scientific / legal documentation.

Ensure preparation, collection, review of regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA / INDs, MAAs / NDAs / BLAs, ODDs, PIPs) as well as Ethic Committees / IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.

Provide expert advice to Clients addressing complex regulatory queries ensuring consistent and high-quality advice across all regions.

Ensure that all communications with Regulatory Authorities and Ethics Committees / IRBs are carefully tailored to the specific requirements and tale place only when essential guidance cannot be obtained through other available resources.

Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.

Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.

Provide training, coaching and mentoring to junior members of staff.

Qualifications

Minimum 3 years within CRO industry

Proven ability to successfully manage global projects

Expert knowledge of ICH GCP and / or GVP and comprehensive understanding of relevant legislation / regulatory requirements globally

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer :

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

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