Vacancy Announcement for the position of: Senior Regulatory Affairs Officer

Job Description/ Responsibilities:

  • Studying scientific and legal documents.
  • Gathering, evaluating, organizing, managing and collating information in a variety of formats.
  • Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Maintaining familiarity with company product ranges.
  • Planning, undertaking and overseeing product trials and regulatory inspections.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Analyzing complicated information, including trial data.
  • Offering advice about company policies, practices and systems.
  • Obtaining marketing permission.
  • Outlining requirements for labeling, storage and packaging.
  • Using a variety of specialist computer applications.
  • Liaising and negotiating with regulatory authorities.
  • Providing advice about regulations to manufacturers/scientists.
  • Writing comprehensible, user-friendly, clear product information leaflets and labels.
  • Ensuring that quality standards are met and submissions meet strict deadlines.
  • Preparing documentation.
  • Any other task assigned by the management.

Educational Requirements:

  • M.Pharm/ M.Sc in Chemistry/ Biochemistry.
  • Candidates having MBA from any reputed university will get preferences.

Experience Requirements:

  • Minimum 5 years of relevant experience is required.
  • The applicants should have experience in the following business area(s): Chemicals manufacturers, Pharmaceuticals manufacturers, Medical devices manufacturers, Herbal treatments manufacturers, Pesticides manufacturers, Veterinary treatment manufacturers, Homeopathic medicine manufacturers, Research organizations, MHRA

Other Job Requirements:

  • Age limit: Maximum 35 years as on 30 April 2017.
  • Male and female both can apply.
  • Must have good communication skill in both English & Bengali.
  • Must be sincere, self-motivated, proactive and team player.
  • Should be able to work under pressure and for long time.
  • Proficiency in Microsoft office application is a must.
  • Collaborate with both internal departments (production, maintenance, departmental head) and external departments (government administration, agencies) to direct Human Resource, Administrative and Compliance issues to appropriate existing channels for investigation and resolution.
 
 

Or, Please send your Resume alongside a cover letter to: hr@libragroupbd.com

Application Deadline : April 30, 2017

www.libragroupbd.com