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Job Details

Associate Director Regulatory Affairs

Company: Umbilical Life
Location:
Reference: AB-Reg
Closing Date: 09 Mar 18
Type: Permanent
Salary (£): On Application
Benefits: Competitive Salary, Benefits, Bonus and Progression

Job Summary:

Avni Bhayani at Umbilical Life is recruiting a permanent experienced Associate Director Regulatory Affairs EU/ROW for an expanding company based in London. This role is to provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical.

Requirements:

 

Core Responsibilities

Accountable for maintaining a process and establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs.

Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings. Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics.

Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure.
 

Responsibilities

  • Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion.
  • Determining work processes and resource needs, and must be knowledgeable in applying the IFPMA, ABPI, EFPIA codes of conduct and build a network to ensure adherence to local country regulations and codes of conduct for markets where our products are marketed.

Experience

  • Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
     
  • Expertise with ATMP/Gene Therapy, Medical Devices, or Vaccines
     
  • Minimum of 10 years of increasingly responsible experience in the pharmaceutical industry.
     
  • Experience in clinical trials, regulatory agency scientific advice meetings and business development is preferred
     
  • CRO/Consulting and customer facing experience is preferred
     
  • Expert knowledge of ICH and other global regulatory guidelines
     
  • In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc

 

Apply for this job: Associate Director Regulatory Affairs

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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