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Regulatory Affairs Officer

Regulatory Affairs Officer

  • Location

    Devon

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Market related

  • Contact:

    Oshae Okolo

  • Contact email:

    Oshae.Okolo@catalystcareers.com

  • Contact phone:

    02035899300

  • Job ref:

    LM47997

  • Published:

    12 months ago

  • Expiry date:

    2019-10-09

Role Title: Regulatory Affairs Officer

Employment Type: Permanent

Location: South Devon

Role Summary

  • One of our most successful clients based in South Devon currently have an opening for a Regulatory Affairs Officer to join their Regulatory Affairs team

Role responsibilities

  • New countries will be identified by the export manager which will require successful project management of the registration of products
  • Manage the requirements of the local distributor/agent
  • Responsible for the project planning process to support the submission of the product licences applied for by TP to attain the targets set by the licensing strategy.
  • Preparation and co-ordination of reports to Regulatory Agencies
  • Support the drug safety system (pharmacovigilance)
  • Responsible for the generation as well as submission of technical, complexed and scientific documentation to Regulatory Agencies
  • Development and implementation procedures for the submission of regulatory documents in eCTD (electronic common technical document
  • Procedures must be developed and implemented for provision & registration of products
  • Manipulation as well as management of data using the electronic documentation system, (Q-Pulse) and laboratory information system (LIMS).
  • Input into the pharmacovigilance system in liaison with the PV Specialist for registration overseas.

Candidate requirements

  • Educated to degree level – life sciences degree (hons) or equivalent pharmaceutical experience (5 years+)
  • Project management qualification
  • Knowledge of international and national licensing processes & legislation
  • Experience in presenting information of complexity to large groups
  • Experience (2 years+) of working within the Pharmaceutical Regulatory Industry
  • Communication and interpersonal skills

If this role is of interest to you and your experience and skillset meets the requirements, please don’t hesitate to apply. If you do not receive application feedback within 3-5 working days, please regard your application as unsuccessful on this occasion, however we will store your details so that if any other roles relevant to you come up in the future we will get in touch.

Not quite for you?

If you feel that the role isn’t quite for you, please feel free to send me an email on oshae.okolo@catalystcareers.com or call 0203 589 9284 for a confidential discussion regarding potential opportunities.

Referrals?

We offer a generous referral scheme so if know of somebody who may be a good fit, we provide up to £250 upon successful placement for anybody you refer.

Catalyst Life Sciences

Catalyst Life Sciences is a recruitment company which is part of the JCW Group operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical Information
  • Medical Writers
  • Medical Affairs
  • Compliance
  • Audit
  • Validation
  • Production
  • Manufacturing
  • Clinical Trials
  • Clinical Research
  • Project Management
  • Finance

If you are interested in new roles, but feel this position is not suitable, please feel free to get in touch on oshae.okolo@catalystcareers.com or 0203 589 9284 .