Manager, Startup and Regulatory Affairs

Company Description

Ergomed PLC is a rapidly expanding full service midsized 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, wellbeing 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 highquality 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 Manager, Study Start Up and Regulatory is responsible for developing the strategy based on regulatory requirements and for completing study startup and regulatory deliverables based on an established regulatory SSU RA management plan. They actively assist senior management in securing new business by participating to BDMs and contributing to proposalsbudgets. They also provide strategic guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff.

Main responsibilities include:

• Assume leadership and functional representation for projects andor deliverables of mediumhigh complexity ensuring effective and rapid coordination and management and execution of SSUregulatory 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.
• Provide strategic input to internal and external customers and promptly identify and address any riskpotential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
• Ensure preparation, collection, review of regulatory information and documents to support submissions to FDA, EMA and national authorities (CTAINDs, MAAsNDAsBLAs, ODDs, PIPs) as well as Ethic CommitteesIRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
• Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
• Develops and manages integrated site startup timelines and reports weekly progress including plans to address potential timing risksgaps.
• Provide expert advice to Clients addressing complex SSUregulatory queries ensuring consistent and highquality advice across all regions.
• Ensure that all communications with Regulatory Authorities and Ethics CommitteesIRBs are carefully tailored to the specific requirements and tale place only when essential guidance cannot be obtained through other available resources.
• Reviews the project SSU budget and scope of work with the project PM against project milestones and budget to ensure project profitability. Proactively discusses corrective measures with the project PM where necessary to keep project in line with budget and gross profit expectations.
• 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.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for auditsinspections and provide responses to any findingsfollow up questions.
• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.
• Drive department company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan).

• Qualifications

  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 leadingproject management role
  • Proven ability to successfully manage global projects
  • Expert knowledge of ICH GCP andor GVP and comprehensive understanding of relevant legislation regulatory requirements globally
  • • Excellent organizational and management skills are essential attributes
    • Excellent planning, strategizing, managing, monitoring, scheduling, problemsolving and critiquing skills
    • Exceptional written and verbal communication skills to clearly and concisely present information
    • Outstanding interpersonal skills in a fastpaced, 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 selfmotivation 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.

      Additional Information

      We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a humancentric 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 Offer:

      • Competitive salary
      • Dynamic team of colleagues in a fastgrowing company – possibility for your quick career growth
      • Multicultural environment, English as a company language
      • Strong emphasis on personal and professional growth

      • #LIremote