Regulatory Affairs Director

Regulatory Affairs Director (Biotechnology)

£85,000.00 (Plus benefits)

Manchester area

You don’t get much more innovative than a biotechnology company focused on using biological technology to help with common dermatology issues.  This technology is the latest in medical support, helping cure conditions that have previously had medicines produced that are both expensive and ineffective. 

With a pipeline of more than 8 different products, they are quick on their way to developing a very strong industry reputation as one of the most up and coming businesses in the Manchester area.

The Company

As above this leading biotech company are forging the way in the dermatology industry as being the best in curing certain contagious diseases and conditions using a highly modern medicinal tactic (happy to discuss more on the phone about how they are doing this).

With the use of this futuristic technology they are changing the healthcare world for the better…

The Role

This exciting business are currently looking to expand their regulatory department by introducing a Regulatory Affairs Director to the business. 

The successful candidate’s role will be to:

• Provide regulatory strategy guidance in relation to new topical drug formulations that are in development presently
• Lead regulatory activities with focus on regulatory compliance for clinical trials
• Supervise QA aspects for the company internal and external manufacturing activities (specifically relating to clinical QA)
• Build and re-establish strong relationships with relevant regulatory bodies and industry partners
• Liaise and communicate with consultants representing the business from a regulatory standpoint

(Compulsory) Requirements

• At least 3 years in biotech or early clinical phase development (regulatory affairs)
• Proven track record in leading submissions and engagement with UK and EU regulators and familiarity with the USA and other regulatory requirements
• Knowledge of GxP requirements