Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Organisational restructuring and resource requirements

BioVentures Consulting Limited has worked on many different client sites and in many different organisational structures for delivering regulatory affairs objectives. We recognise that the role of the regulatory affairs professional varies, dependent on both location and organisational structure. For example, there is local office vs local operating company; global structure vs EU or other regional differences; and regulatory professionals based on manufacturing facilities. The definition of roles and responsibilities is crucial for success. In this regard, BioVentures Consulting Limited offers organisational restructuring consultancy services and resourcing advice to clients. We can help Regulatory Affairs Departments increase ‘share of voice’ and demonstrate their value within their organisations through the way the regulatory affairs professionals demonstrate credibility to stakeholders. We recognise the regulatory professional needs to interact with the product team leader, the commercial lead, operations manager, clinical development lead, patent lawyers, drug safety, statisticians, pharmaceutical development, clinical research and project management. BioVentures Consulting Limited can provide organisational restructuring consultancy to facilitate stakeholder credibility. For example:

  • What are the expectations of other functions? Do they understand the role and responsibilities of the regulatory affairs professional?
  • In what ways do other functions rely on the input from regulatory affairs?
  • Should project leadership come from the project management group or the medical lead or the regulatory affairs project manager?
  • Should regulatory affairs be advising, leading, driving or challenging other members of the development team? T
  • To what extent can other functions be left in charge of drug development?
  • Who does the organisation turn to when things go wrong?
  • What skill sets are required by the regulatory affairs professional for this? (more than an individual with tact and diplomacy!)
    • Is the regulatory functional leadership a member of other leadership teams or governance committees?
    • Who is best placed to interact with Health Technology Agencies, other pharmaceutical companies, key opinion leaders, trade associations, external CROs and regulatory agencies?
  • Is the regulatory functional leadership a member of other leadership teams or governance committees?
  • Who is best placed to interact with Health Technology Agencies, other pharmaceutical companies, key opinion leaders, trade associations, external CROs and regulatory agencies?

We are able to act not only as a sounding board but also as partners who can provide creative suggestions and solutions

BioVentures Consulting Limited can advise and provide resourcing solutions as appropriate for the organisational structure of our client’s regulatory affairs department. For example:

  • What is the optimal strategic vs operational mix?
  • What should the balance be between regulatory affairs associates and more experienced officers, managers or executives?
  • How should the brief of the regulatory project manager be defined and how many should there be for a given project at each stage of development?
  • What type of specific expertise might be expected in 3-6 months time? For example, Emerging Market expertise, CMC Quality expertise for forthcoming site or process changes, or Regulatory Systems and Compliance managers following a merger of acquisition?
  • What should the mix be between contract and permanent staff?
  • When should more experienced interim consultants be brought in and for how long?

With regard to organisational restructuring and resource requirements the experience and expertise BioVentures Consulting Limited can be highly valuable. We are able to act not only as a sounding board but also as partners who can provide creative suggestions and solutions.

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