Director of Regatory Affairs
- Experience Level
Josh Zarembski is pleased to offer to the market a fantastic opportunity to join an International CRO that offers excellent prospects for future development.
With a quick onboarding process to enable a simple transition this organisation is looking for an Associate Director of the Regulatory Affairs team in Berlin.
This position offers flexible, remote working and an open culture based upon the company values. These include learning, customer focus & Accountability. The perfect candidate is an individual with a committed, tenacious, determined attitude and the desire to help this CRO move to the next level.
As the Director of Regulatory Affairs, you will be responsible for direct line management, including the full cycle of staff management from hiring, onboarding, mentoring, performance management, talent development, process, and system compliance, as well as appropriate resourcing.
- Provides strategic and tactical leadership in terms of regulatory submissions in line with established strategies and timelines
- Ensures overall quality and timeliness of regulatory deliverables
- Assumes direct responsibility for process definition and compliance with related functional areas (SOPs, Working Instructions, study specific execution documents)
- Acts as the main point of contact for clients and subcontractors (partner CRO) for all aspects related to clinical study registration to Competent Authorities and Ethics Committees
- Develops country regulatory intelligence data related to clinical study application and amendment submissions to Competent Authorities and Ethics Committees
- Supports the company in scope of new business opportunities; attends Bid Defense Meetings
- Represents the company on relevant industry events
- Defines and executes metrics for relevant business line
- Supports the development of processes related to other functional areas
- Supports more junior team members with more complex submission requirements
- Acts as a role model for Regulatory staff demonstrating leadership, ownership and accountability
- May take on the role of Regulatory Lead on projects as per business needs
- Reviews clinical study application and amendment submission packages before submission to Competent Authority and Ethics Committee for completeness, accuracy and ensures that corrections are implemented appropriately
- Maintains in-depth knowledge on regulatory country requirements, EU and international requirements, laws and regulations related to clinical study applications and amendments to Competent Authorities and Ethics Committees by regularly monitoring relevant resources and websites. Communicates relevant updates to stakeholders
- Prepares reports on the assigned activities according to the requirements and timelines established by the Head of Central Clinical Operations Services
- Participates in Kick-off meetings, audits and other project related meetings according to company / client needs
- Participates in internal and external teleconferences/meetingsPeople Management and People Supervising Responsibilities
- Regulatory Team (6-10 members)
- Coaching and development of junior staff (cross-cultural, cross-country)
- Ensuring scalability of supervised area
- Minimum of Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree preferred
- Extensive experience in Regulatory Affairs work or related work in a Clinical Research environment
- In-depth knowledge of ICH/GCP guidelines, national and international regulatory requirements, European regulations and Standard Operating Procedures
- Strong understanding of clinical trial registration process
- Ability to work independently and efficiently with little management supervision
- Ability to work in a dynamic fast-paced, high volume environment and meet deadlines
- Excellent problem-solving abilities
- Strong organizational and time management skills in order to balance working on multiple projects in parallel
- Excellent interpersonal, influencing and negotiation skills as well as excellent verbal and written communication skills
- Excellent planning, analytical, project management and leadership skills
- At least 2 years of international people management experience: ability to effectively supervise a team of people
- Computer competency
- Fluent in local office language and in English, both written and verbal
Available for travel occasionally, including overnight stays as necessary, consistent with project/departmental needs and office location. Ability to travel locally and internationally.
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