Regulatory Manager / Senior Manager (Devolpment)

Location
Essex
Salary
Competitive salary and benefits
Posted
03 Oct 2019
Closes
02 Nov 2019
Ref
0310RMSMD
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

DETAILS:

  • Full-time permanent position
  • Office based in Essex
  • Competitive package
  • Global pharma company

 

THE ROLE:

The Regulatory Manager/Senior Manager will provide the following expertise-based services:

  • Point of contact for agency interaction
  • Provide expert EU regulatory strategy
  • To be a client lead
  • Provide leadership in scientific advice meetings at national agencies and EMA
  • Project management/lead responsibilities
  • Client facing with strong communication skills, willing to travel
  • To assist the company in providing regulatory knowledge to business development colleagues during bid defence
  • To lead EMA procedures including orphan applications, PIP’s, scientific advice briefing documents, etc.

Full job description available on application

 

THE CANDIDATE:

Essentials

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
  • 3+ years European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities
  • Demonstrable experience in scientific advice meetings, CTA, orphan applications and/or PIPs
  • Strong understanding of the regulatory environment including guidelines
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills
  • Collaborative approach and able to work effectively with matrix-based teams involving internal staff, client teams that include independent consultants

Preferences:

  • >5 years of experience in regulatory affairs based activities and regulatory authority interactions
  • Exposure to MAA dossier writing and submission procedures
  • US FDA facing experience
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

Apply for Regulatory Manager / Senior Manager (Devolpment)

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

All questions are required

Do you hold the right to work in the UK?


Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs