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Current Assignments


Below is a selection of interim assignments that Interea is currently working on. Please note that the list is not exhaustive, and is intended primarily to demonstrate the wide range of roles with which we are asked to help.

If you have an interest in any of the assignments listed below, please contact Interea as soon as possible.

Interim Regulatory Affairs Director : EMEA

Our Client is an ambitious speciality pharma company, publicly quoted and with revenues in excess of $1 billion.  Global headquarters are in the US, with European operations managed via a base in the UK.

The company currently has a portfolio of pioneering and innovative products that are available in over 40 countries around the world and which help treat patients for a condition that is recognised as one of growing public health concern.

Other key products are in development and are expected to contribute significantly to the company’s future global growth in the coming years.

The need has emerged for an Interim Regulatory Affairs Director : EMEA who will be responsible for leading all regulatory affairs activities across Europe / EU and Middle-East Africa.

This is a senior level role, reporting directly to the Senior VP Global Regulatory Affairs in the US.

Key responsibilities include:-

  • Leading a team of regulatory professionals across Europe
  • Liaising directly with EMEA Regulatory Authorities
  • Defining global regulatory strategies and submissions in support of new and existing marketing authorizations.
  • Regulatory compliance

This interim assignment is expected initially to be of 6-12 months duration, probably demanding 4-5 days per week.  The successful candidate will be based in the European HQ in Greater London / Thames Valley, although it is likely that some work some work can be conducted from a home base. A modest amount of international travel will be required.

For the right candidate, the possibility exists for a subsequent transition into a permanent position of employment.

It is likely that the successful candidate will have…

  • Advanced degree in Pharmacy/Medicine/Pharmacology/Chemistry/Biology or other science-related field.
  • Master Degree in Regulatory Affairs a plus.
  • Minimum of 15 years of experience in the pharmaceutical regulatory field
  • Minimum of 4 years experience in a senior Regulatory position at European level
  • Minimum of 4 years experience in Regulatory Affairs Director position within a EU5 country
  • Previous people management experience across countries is required
  • Working knowledge of Regulatory Affairs regulations and major European health authorities. Knowledge of Middle-East regulations is a plus.
  • Experience of working in a specialty care category/disease space e.g.,psychiatry, mental health, stigmatizing diseases (HIV-HCV, alcohol addiction) is essential. Experience in controlled substance regulations is a plus.

This is an outstanding and exciting opportunity in an ambitious and fast-growing company.  The contribution to be made will be highly visible and of critical importance.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@interea.co.uk

Interim Head of Supply Chain

Our client is a privately-held, venture backed business that has genuine expertise in encapsulation technology that enables valuable active products to be protected, delivered and released where and when required.

Such technology has the potential to be of real interest to a wide range of industry sectors including pharmaceuticals, detergents, agrochemicals, cosmetics, fragrances etc.

The need has emerged for a interim Head of Supply Chain for an assignment of 3-6 months duration, probably averaging 10 days / month.  Extension of the assignment is a genuine possibility.

Key deliverables as follows:-

  • Implementation of S&OP software (vendor has just been selected)
  • Support of talented analytical chemist in assumption of role of QA lead
  • Identification of 2ndsource of manufacture in EU (Brexit) most probably Ireland
  • Set up identified contract manufacturers for finished packing of 2 products
  • Implementation of smooth supply chain for launch of a product through an on-line retailer in Sept.

This is an excellent opportunity in a company of outstanding potential.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@www.interea.co.uk

Comercial Lawyer : Biotech

Our Client is an ambitious and fast-growing specialist Process technology / Contract Manufacturing Organisation (CMO) highly active on the business development front in the US as well as Europe and Japan.

The need has emerged for an experienced biotech commercial lawyer to advise them on contract development and manufacturing agreements with customers , mainly in the USA but in EU and Japan.

This is an interim role.
Candidates must be experienced in biotech CDMO dealmaking .
If this opportunity is a good fit for you, please contact Geoff Newman at Interea as soon as possible.

 

Interim (or Permanent) Regulatory Affairs Associate : Medical Devices

Our client is a well-financed, UK-based company operating within the medical devices sector and with plans to move to profitability within the next couple of years on the back of a number of product launches.

The company currently has over 20 employees including a strong technical team (of which the Regulatory Affairs function is a key part) led by a Chief Technology Officer (CTO). To underpin ambitious growth plans and build greater depth and expertise in the team, the company is seeking to appoint a Regulatory Affairs Associate with experience of regulatory affairs in relation to medical devices.

This is a crucial role for the successful expansion of the company into a substantial business over the next several years so the job holder will have a high level of influence in shaping the success of the business as it goes forward.

The Regulatory Affairs Associate role report directly to the Head Of Quality &Regulatory affairs. It is likely that the regulatory function will continue to grow.

The successful candidate will be responsible for directly submitting and maintaining regulatory approvals, under the direction and guidance of the Head of Q&RA.

Specific Responsibilities

  • Leading the preparation and submission of regulatory approvals in the markets served by the company. These include (but not limited to): EU, USA, China, Canada, Australia, New Zealand, Israel, Middle East, Korea
  • Participating in ensuring compliance with all applicable standards and regulations for the company’s medical devices

 Rapid expansion into new markets and territories along with the launch of new product upgrades are planned, requiring new and amended regulatory clearances.

 

Experience, Skills and Abilities

  • Strong background in regulatory affairs for medical devices, with at least 5 years of relevant experience.
  • Experience in the medical devices industry essential
  • Good knowledge and experience of EU regulations and guidance required
  • Good knowledge of ISO13485 and ISO14971 highly desirable
  • Experience of FDA 510(k) submissions highly desirable
  • Educated to degree level in a relevant discipline
  • Good time management, thoroughness, attention to detail and organisational skills.
  • Excellent communication skills, both verbally and in writing, using correct terminology with staff and partners at all levels.
  • Self-motivated and able to work independently, but to do so in the context of the wider team.
  • Able to understand the context of their role within the commercial objectives of the company, and have the necessary degree of pragmatism, flexibility and sense of urgency to succeed in a small company environment.

 

This interim opportunity will be of a initial 6-months duration and will demand 3-4 days / week.  It is highly likely that a subsequent transition into a position of employment could follow if so desired.

If this opportunity is of interest, please contact Geoff Newman of Interea as soon as possible.

Interim Key Account Manager : Branded OTC Medicines

One of Interea’s good clients is a UK-based company that has two distinct sides to its business – one of which is the already successful (and growing) commercialisation of branded OTC medicines, here in the UK and in an expanding number of other European markets.

Within the UK, consumers can already buy the products in such major multiples as Boots, Superdrug, Morrisons and Tesco, and efforts are underway to secure distribution agreements with other important chains such as Waitrose, Asda etc.

An Interim need has arisen within our client for a Senior Key Account Manager who will have responsibility for the profitable sales into these retail channels. It is important that the professional relationships between our client and the buyers within these companies continue to grow and develop to both parties’ satisfaction.

The interim assignment will be of an initial 6-9 months duration, with the genuine possibility of a subsequent transition into a permanent position of employment if both parties so wish. The assignment will probably demand not less than 3-4 days / week.

Our client’s Head Office is in London, although it is envisaged that the successful candidate will essentially work from a home base. Occasional visits to London will be necessary.

Ideally, the successful candidate should be in a position to start the assignment as soon as possible.

If this opportunity is of interest and a good fit with your own areas of experience and expertise, please contact Geoff Newman of Interea International as soon as possible.

Phone 01844 – 202989 or email to gn@www.interea.co.uk

Interim IT Professional

A critically important interim need has arisen in one of Interea’s very good clients – a UK-based pharmaceutical CMO that is highly ambitious and who have very recently raised a significant amount of money in order to build a new facility.

This will transform the company from one that currently employs c. 20 people to one that will employ closer to 100 and will allow them to manufacture not just early clinical drug supply, but quantities sufficient for all stages of development as well as commercial quantities.

Not surprisingly, there is much to do on the IT front.

In brief, their need is for an Interim IT professional to run a conceptual design and implementation project for their new facility.

Ideally they are looking for someone who has experience of setting up an IT system (ground up) who has a background in the Life Sciences industry and experience in integrating quality systems (GMP in this case), Laboratory Information Management System (LIMS), financial systems, inventory management and operational planning.

The assignment is likely to of an initial 6 months duration, but with the probability of extension.

Difficult to say at this stage how many days / week the role will demand, but will not be less than 3-4, and could well be full time.

Ideally, the successful candidate should be in a position to start the assignment as soon as possible.

This is an excellent opportunity in an exciting company.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@www.interea.co.uk

Interim Director of Finance

Our Client is a not-for-profit organisation and a registered charity that has significant interaction with pharmaceutical and biotechnology companies on a global basis.

The need has emerged for an Interim Director of Finance, with the assignment having an initial duration of 6 months.  The exact number of days / week has yet to be finalised.

Candidates must be qualified accountants and have experience of working in a financial role within the charity sector.

If this unusual and challenging opportunity is of interest to you, please contact Geoff Newman as soon as possible.

 

Marketing Professional : Agrochemicals

If you are a successful marketeer with proven experience within the agrochemicals sector (Syngenta ?, Monsanto ?), then we would like to hear from you.

One of our existing clients is a unique, exciting and ambitious company –  one that has created a new role that will demand candidates of the highest calibre.

This is a permanent role (not interim), UK-based but international in outlook.  Well compensated.

If this opportunity is of interest, please contact Geoff Newman as soon as possible (gn@www.interea.co.uk     01844 – 202989)

 

Interim UK Marketing Professional : Aesthetics

An urgent and important interim need has arisen in one of Interea’s long-standing clients – an international healthcare company specializing in both prescription and over-the-counter products that meet patients’ needs in a small number of well-identified fields.

One such area is that of aesthetics, where the company has an important product launch planned for later this year. This is a device with consumables and is CE marked. It is already commercialised in the US.

The need is for an experienced UK marketing professional, familiar with the field of aesthetics, but who is also likely to have experience of pharma and device / OTC.

Experience with social media would be a plus.

The interim assignment is for an initial period of 3 months, as close to fulltime as possible.

This is an excellent opportunity in an exciting company.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@www.interea.co.uk

Senior Project Manager (Clinical) : Interim

Our client, based in the UK, is a well funded, small, rapidly growing and ambitious speciality pharma company currently at a very exciting stage in its life.

With two innovative products already in phase III and others in Phases I and II, they are optimistic of being in a position to make initial regulatory submissions later this year that would then allow for subsequent commercialisation of their first product late 2017 / early 2018.

The need has emerged for a talented, motivated and experienced Senior Clinical Project Manager to join the company in what is a critically important role.

This is an Interim role, likely to be (initially) of 6 months duration and demand 3-4 days / week.   For the right person, this has the possibility of subsequently transitioning into a permanent role.

The successful candidate will primarily be working from a home base, but visits to the CRO will clearly be important as will occasional visits to the company’s offices in London.

Reporting directly to the company’s Medical Director, and working primarily on at least two Phase I studies, key areas of responsibility are as follows:-

  • Provide the necessary expertise to support the company by providing clinical project management (including planning, implementation and execution) for the Company’s key development programmes
  • Specifically, to manage clinical studies to ICH-GCP standards, UK Statutory Instrument requirements and in line with the Company’s SOPs
  • To manage or participate in the selection process for clinical CROs; to assist in the preparation and review of study protocols and other study specific documentation
  • To ensure consistency in protocol and CRF design, data management processes and related study specific documentation; to act as single-point of contact with the appointed clinical CROs conducting the Company’s studies
  • To ensure sufficient resources are available to manage and monitor the Client’s studies
  • To review clinical monitoring plans in accordance with the Company’s SOPs
  • To co-ordinate monitoring of clinical studies in accordance with pre-prepared monitoring plans
  • To co-ordinate the supply of study medication including facilitating the forecast, distribution, returns and destructions of such material
  • To track study progress and report any issues to the Medical Director or Quality Manager
  • To assist in the writing, compilation and/or review of clinical SOPs; to maintain an understanding of the external environment for conducting clinical research in Europe.

 

This is an excellent opportunity in an outstanding company of real potential – one with whom Interea has worked many times in the past.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@www.interea.co.uk

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