RA CMC Director

€0.00 - €120000.00 per annum
  1. Permanent
  2. CMC
  3. Germany
Munich, Bayern
Posting date: 21 May 2019

An international pharmaceutical company are looking expand their regulatory team by hiring a Director Regulatory Affairs - Biosimilars. This organisation prides itself on its unique approach to partnerships, having established a strong market presence that covers the world's pharmaceutical markets. Based in Munich, this position is an exciting opportunity to work with a globally renowned company that delivers significant results and improves the lives of patients who need their medicine the most.

Job Responsibilities:

  • Developing, supervising, and managing the regulatory activities and submission strategies.
  • Ensuring that the biosimilars business unit aligns with Quality functions to maintain compliance.
  • Planning and controlling the regulatory and regional budgets, tracking costs incurred against the budget, preparing budget reports and direct costs, consulting oversight, and ensuring the leads are aware of the resourcing costs incurred against the budget.
  • Contributing to the strategic development of the organization by maintaining confidentiality and discretion where appropriate.
  • Co-ordinating activities required to maintain directorate licences by acting as the point of contact for authorities (The Home Office).
  • Demonstrating accountability, working closely with relevant stakeholders (Inc. MRL LT, Commercial Asset and Operational teams and global IAC network) in fulfilling functional and product development objectives.
  • Maintaining a lean and efficient biologic/biosimilar team structure (including strategic consultants) to lead all product types in established and new project/therapeutic areas.
  • Preparing, controlling, and monitoring the capital and revenue budgets associated with products and device developments.
  • Assuming responsibility to ensure that each partner/contractor/collaborator is motivated to give a strong commitment to the work of MITO.
  • Coordinating and allocating resources in the evaluation of in licensing opportunities with the Due Diligence teams, MINT and project leadership, and supporting RA early stage opportunity pre-diligence.
  • Effectively leading and coaching internal and external staff and other resources required to meet functional objectives, justify, and inform relevant stakeholders when additional financial or staff resources are required.
  • Actively developing and maintaining a network of strategic vendors, external partners/contractors, and consultants, ensuring that, where appropriate, they are suitably audited, and technical/quality and commercial contracts are established.
  • Agreeing and monitoring the setting and completion of objectives and timelines for projects, in conjunction with asset team members/leaders and other Departmental managers.
  • Facilitating, coaching, and mentoring to deliver high quality leadership (technical & behaviours) and provide a clear career development path for the team.
  • Promptly engaging with Quality Assurance and Technical Development to ensure provision of data and information for incorporation into Regulatory submissions.
  • Demonstrating and applying detailed knowledge and application of EU, FDA, and other Regulatory guidelines for development of products and devices.
  • Actively communicating with other Directors, managers, asset/project team leaders, and other staff to ensure a co-ordinated and collaborative approach to all work.
  • Liaising with global IACs, facilitating project transfers, and ensuring common standards and working practices are adopted wherever possible.
  • Ensuring that Health, Safety & Environmental, COSHH, GLP, and other GXP requirements are complied with at all times. Ensuring external partners/contractors/collaborators are aware of their own responsibilities and obligations in these areas.
  • Carrying out reasonable administrative activities required to comply with Company and Research & Development practices and to ensure smooth day to day running of the department.

Skills and Requirements:

  • Degree or PhD qualified.
  • 10 years pharmaceutical experience in international oversight.
  • Managing international or regional regulatory submissions (full submission process)
  • Experience in using eCTD formats globally
  • Previous experience in biologics or biosimilars
  • Significant experience in the pharmaceutical industry and substantial knowledge of the research and drug development process
  • Understanding of the industry trends and emerging issues in Europe, US, Asia Pacific and Latin America, including social, economic and regulatory factors that might impact the delivery of successful R&D and commercial outcomes.
  • Cultural sensitivity gained from experience within diverse environments.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.