Regulatory Affairs Associate Director – Haematology / Oncology – Global Biotech – Remote (UK/EU only) £competitive basic salary, bonus, pension, healthcare, car allowance (UK), 25 days holiday

This is an exciting opportunity to join a global biotech in their Oncology/Haematology team. You’ll be working on a huge variety of development products within this therapy area, regularly consulting with the EMA.

The Company

This is an exciting, global biotech at the forefront of new pharma products. Specialising in haematology, oncology, neurology and cannabinoids, this company has an exciting product pipeline in development stages, early phase and late phases stages.

• Global biotech
• Specialising in haematology, oncology, neurology and cannabinoids
• Excellent and exciting product pipeline
• Hugely supportive company, keen to develop employees to their full potential

The Role

The Regulatory Affairs Associate Director – Haematology / Oncology will be responsible for EU registration of new products within this therapy area.

• Planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).
• Authoring of regulatory documents (ex. ODD, SA Packages, Meeting Correspondence, GRS)
• Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
• Provide in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports and all types of regulatory documentation (quality, safety, efficacy and labelling) including CTAs

You

To apply for this role as Regulatory Affairs Associate Director – Haematology / Oncology our client is hoping for someone with the following skills and experience;

• Ample Regulatory Affairs experience within Pharma and/or Clinical Trials
• Any therapy areas will be considered, but TA’s of particular interest include; neurology, haematology, oncology, rare diseases, paediatric products
• Regulatory strategy experience
• EU experience is essential, particularly consulting directly with the EMA

What should you do next?

This Regulatory Affairs Associate Director – Haematology / Oncology role is one not to be missed; it encompasses the opportunity to work in a global biotech on some of the most innovative products in the pipeline. To discuss this Regulatory Affairs Associate Director – Haematology / Oncology role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.