Regulatory Affairs Director

Regulatory Affairs Director directs the regulation process for products requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Affairs Director requires a bachelor’s degree. Typically reports to top management. The Regulatory Affairs Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Regulatory Affairs Director typically requires 5+ years of managerial experience.

Regulatory Affairs Director Job Description Template

Our company is looking for a Regulatory Affairs Director to join our team.

Responsibilities:

  • Review and approval of audit and submission documentation;
  • Leading client meetings and conducting client liaison on an ongoing basis;
  • Line management for junior team members;
  • Briefing of clients and internal project teams;
  • Leading the development and implementation of regulatory strategies to realise the commercialisation of healthcare products;
  • Strategic project shaping and leading of process preparation for EMEA submissions;
  • Provide scientific insight for new business pitches and proposals;
  • Provide development related strategy for a broad range of programmes;
  • Regulatory lead and point of contact for national agency and EMA interactions;
  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts;
  • Assist with Business Development activities by taking part in new prospective client-lead discussions;
  • Provide world-class advice in EU regulatory affairs maters across a range of product types;
  • Provide direct line management and matrix team-based leadership where needed;
  • Assist with business development activities by acting as Regulatory Subject Matter expert in prospective client discussions;
  • You will act as the EMA main point of contact and lead on Scientific Advice and other advisory meetings with Regulatory Authorities.

Requirements:

  • Strong scientific and analytical ability;
  • Flexibility to move quickly between projects and work across different therapy areas;
  • Excellent knowledge of the pharmaceutical industry;
  • Minimum of 5 years Regulatory and EMEA submission experience;
  • Excellent interpersonal Skills;
  • Oncology, heamatology, orphan diseases and immunology experience preferred;
  • Proven experience within a team management role – ideally 2 or more years, including leading local and international teams of at least 2 people;
  • Experience in Clinical Literature Evaluation (CER);
  • Experience with active medical devices (software / electronic, IEC 60601 IEC 62304);
  • Experience with liaising with legal counsel, regulatory bodies and agencies;
  • Proven experience of successful submission of complex Class IIb / III active medical devices in China or Russia – essential;
  • Direct experience of device testing;
  • Strong interpersonal skills including excellent communication, presentation and influencing skills;
  • Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy;
  • Bachelor’s degree or equivalent within a relevant subject such as pharmacy, chemistry or a related scientific discipline.