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Job Details

Managing Consultant (EU Clinical Development)

Company: ProClinical Ltd
Location: United Kingdom
Reference: RA.DN.10466
Closing Date: 26 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

My client is a consultancy focused on delivering high quality pre-approval Regulatory services to a variety of emerging and established pharma and biotechnology organisations. They are seeking a home-based Managing Consultant (EU Clinical Development) to be located in the UK. Job Role:The Managing Consultant Regulatory Affairs will work within a multidisciplinary team environment to provide regulatory expertise and leadership. ...

Requirements:

My client is a consultancy focused on delivering high quality pre-approval Regulatory services to a variety of emerging and established pharma and biotechnology organisations. They are seeking a home-based Managing Consultant (EU Clinical Development) to be located in the UK. 

Job Role:

The Managing Consultant Regulatory Affairs will work within a multidisciplinary team environment to provide regulatory expertise and leadership.

  • Development and execution of regulatory / clinical strategies to support timely approval of regulatory applications in support of the client companies corporate objectives.
  • Helping the company and client companies to ensure regulatory compliance.
  • Preparation of excellent Quality Regulatory documentation.
  • Project Management of client projects and representation of the company and client companies at meetings.
  • Project Management of any project work delegated to other consultants on the team.
  • Supporting client regulatory/clinical departments to secure national clinical trial approvals on behalf of client companies.

Essential Duties and Responsibilities:

  • Oversee marketing authorisation applications and clinical trial applications to support exploratory and development projects and ensuring the documentation meets relevant regulatory requirements.
  • Ensure that all necessary support undertakings and obligations are provided for and auctioned when and as required.
  • Oversee the receipt, distribution and response to regulatory queries on the MAA or CT Application consistent with client procedures.
  • Responsible for delivering MAA or CTA approvals and subsequent regulatory maintenance procedures in line with client timelines and goals.
  • Develop, plan and advise client companies on appropriate regulatory submission strategies, and help identify data requirements.
  • Represent the company at meetings with agencies, conferences, meetings and client companies.
  • Represent the company and client companies at meetings with regulatory agencies and other relevant organisations.
  • Keep up to date with, and as far as possible anticipate, new or changing regulatory requirements in relevant territories.
  • Build and develop and train a skilled regulatory affairs organisation.

Job Requirements:

  • Bachelor's degree in pharmacy, a life science or a biomedical discipline.
  • Significant regulatory affairs experience in a CRO, biotech or pharmaceutical company included demonstrated expertise in EU MAA and CT submissions.
  • Ideally you will have significant expertise in all aspects of pre-approval MAA dossier compilation and submission, extensive EMA interactions and input into clinical development some experience in devices would be a plus.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44 203 0789 544 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Managing Consultant (EU Clinical Development)

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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