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Job Details

Associate Director Regulatory Affairs

Company: Planet Pharma Staffing Limited
Location:
Reference: 45890
Closing Date: 22 Feb 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

A mid-sized pharmaceutical companies with a developed network in over 120 countries is seeking an Associate Director of Regulatory Affairs. You will be responsible for leading regulatory strategies for established products across all therapeutic areas. You will also play a key role on geographical expansion strategies on assigned projects This is a permanent position that offers competitive salary and benefits package based in Cambridge, UK.

Requirements:

Company Statement

Our client is a global mid-sized pharmaceutical company with a developed network in over 120 countries and European offices in the UK and Germany. They are global leaders in pain medicine and quickly developing a growing presence in other core therapeutic areas, such as oncology, respiratory and biosimilars. Their strong code of ethics and core values, such as commitment, innovation and mutual respect contribute to the successful development of medicines that add value for patients and providers around the world..

Role/ Description

Responsibilities:

  • Responsible for leading regulatory strategies for established products for all therapeutic areas
  • Responsible for providing regulatory expertise to the commercial Established Brands team
  • Provide training and mentoring to other members of staff in regulatory affairs
  • Ensure efficient and timely provision of regulatory services to outsource partners
  • Responsible for the management and maintenance of MA application for commercial expansion plans
  • Collaborate with regulatory agencies regarding MA application, renewal and variation questions
  • Provide support to independent associates companies regarding registration and maintenance activities of Mas
  • Stay up to date with current regulatory requirements and provide expert advice and guidance on issues that impact the company

Requirements:

  • Science degree or equivalent
  • Extensive experience in regulatory affairs, MA maintenance and lifecycle management
  • Proven experience managing post-approval products, including expansion
  • Able to work across multiple projects
  • Strong strategic, communication and interpersonal skills

 

About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3868 1000 or e-mail on EURecruiters@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Keywords 

Regulatory Affairs, submissions, Market Authorization, established products, renewals

 

 

Apply for this job: Associate Director Regulatory Affairs

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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