Company

KCR

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(Associate) Director Regulatory Affairs

City/voivodeship

Berlin

Publication

2021-01-12

Company description

KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.
KCR: We see human behind every number

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com. We see human behind every number.

(Associate) Director Regulatory Affairs

Workplace: Berlin


The Associate Director Regulatory Affairs provides leadership and management to direct the delivery of activities related to study level submissions and authorizations, within and across projects. Responsible for directing and leading the activities of the Regulatory Affairs team, responsible for functional leadership, process set-up/improvements, and related system development. This pertains to inputs on study designs, global management of study authorizations as well as liaising with concerned teams and vendors in scope in regulatory authorization management. Represents the business unit towards internal and external stakeholders, supporting company growth and development.

The role of the (Associate) Director Regulatory Affairs includes direct line management responsibilities, including the full cycle of staff management from hiring, onboarding, mentoring, performance management, talent development, process and system compliance, as well as appropriate resourcing.

Responsibilities:

  • 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/meetings

People 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

Requirements:

  • 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

Travel 

  • Available for travel occasionally, including overnight stays as necessary, consistent with project/departmental needs and office location. Ability to travel locally and internationally.

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with:

  • Outstanding opportunity to join an international CRO organization that offers excellent prospects and development
  • Onboarding process to enable you fast takeover of duties
  • Peer/ Buddy/ Mentor who will introduce you to the organization
  • Flexible, remote working options
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed
  • Empowering workspace, offering opportunities to share ideas
  • Mentoring and training programs related to clinical trials, therapeutic areas, soft skills development 
  • Additional days-off for certain occasions