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Job Details

Regulatory Affairs Manager - Biotech

Company: Barrington James Clinical
Location:
Reference: CRBG-RGMAN
Closing Date: 07 Jan 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

For more details, please call Carlos Biggemann on +44(0)1293 776644 or email cbiggemann@barringtonjames.com

Requirements:

This is an excellent opportunity for an established and highly experienced Regulatory Affairs professional to join us at this pivotal time, offering a rare opportunity to support the regulatory activities for a new product across Europe and US.

About you:

This role merits an individual with a high level of Regulatory Affairs acumen; who has excellent leadership and cross-functional management skills, the confidence and ability to work independently and be a decision maker.

To be successful in this role you will have:

Expert Regulatory Affairs experience, preferably with orphan drugs in Europe and the US

Excellent negotiation, verbal and written communication and interpersonal skills

The ability to think strategically and develop global regulatory strategy whilst balancing local/affiliate needs

Good analytical and problem-solving skills

Good organisational and project management skills and high attention to detail

Key accountabilities and responsibilities include:

Management of compliance with relevant regulatory legislation and guidelines

Defining project and product regulatory strategy in line with commercial and company strategy, consulting with appropriate departments when necessary

Liaising with regulatory authorities

Provision of expert regulatory advice to other departments in the organisation, and regulatory support to licensing partners in the EU and other territories

Ensure communication of changes in business-critical legislation/regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner

Pro-actively identify potential obstacles to approval of regulatory submissions and manage the resolution of issues

Regular contact with regulatory authorities and external consultants working on behalf of the company as required.

The ability to understand and present complex scientific arguments

Benefits:

Competitive salary

Pension scheme

Private medical insurance

Other voluntary benefits include: Childcare Vouchers, Bike to Work

Apply for this job: Regulatory Affairs Manager - Biotech

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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