SENIOR) SPECIALIST REGULATORY AFFAIRS/START-UP

Company Description Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 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 The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU  RA management plan.
They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.
DUTIES AND RESPONSIBILITIES.
• Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact.
Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently.
• Prepare, collect, review 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.
• Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation.
Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
Prepare study team reports or updates regarding status of essential document collection, review and approval.
• Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and regulatory/EC submissions/approvals.
• Participate in ICF development, review, negotiation and approval processes.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
• Support feasibility, site identification and site documents customization (i.
.
informed consent document) as needed and closely follow up with investigative sites for updates/resolution.
• Arrange for and/or review translation of essential documents as required.
• Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
Qualifications Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience.
Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
Previous experience in Clinical Trial Regulatory submissions.
Excellent oral and written communication skills.
Excellent interpersonal and organizational skills with strong attention to detail.
Good customer/client relationship management and proactive problem-solving skills.
Knowledge of the principles, methods, and procedures of clinical research.
Good computer skills including MS Word, Excel, PowerPoint, Outlook.
Experience with ICH/GCP documentation and process preferred.
Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.
Additional Information We offer excellent chances to progress and develop.
We work on a global basis on interesting projects within rare diseases, oncology, and neurology.
This is an ideal position to continue developing a career in clinical drug development.
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.
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