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Regulatory Affairs Manager

Company Description


Ergomed PLC 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.

Due to continued growth, we are seeking a Computer Systems Validation/IT QA Specialist


Job Description


Ergomed is looking for a Regulatory Affairs professional with in-depth Clinical Trials experience, who would like to expand their knowledge to full life cycle management including Orphan Drug Designations, Paediatric Investigational Plans and Marketing Authorisation Applications to join our expanding team.

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.

KEY RESPONSIBILITIES:

  • Prepare, collect, review and submit documentation related to clinical studies (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.) to the relevant regulatory authorities and IRB/EC and act on the Sponsors behalf in liaising with these authorities
  • Act as Regulatory Lead for global clinical trials of low/medium/high complexity ensuring effective and rapid coordination and management of regulatory & ethics committee submission, striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
  • Evaluate, prepare and submit documentation related to Orphan Drug Designation Requests, PIPs and Market Authorization applications as requested with guidance from senior members of the team and external consultants as appropriate
  • Assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets.

Qualifications
  • Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Minimum 4 years of regulatory experience within pharmaceutical/CRO industry
  • Preferably one proven area of expertise within the regulatory affairs environment (i.e. CMC, MDs, Orphan Drugs, Advance Therapies, etc)

Other skills and abilities:

  • Previous experience in managing clinical trials globally
  • Clear understanding of ICH GCP across all areas
  • Good written and verbal communication skills to clearly and concisely present information
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

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

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.

#LI-Remote

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