Regulatory Affairs & Safety Project Manager Adriatic

Regulatory Affairs/Clinical Affairs Sofia, Bulgaria


Descripción

You will assume responsible for regulatory and safety operations in Adriatics region. Managing regulatory and safety operations and projects in the Adriatic countries including Bulgaria, Slovenia, Croatia, Bosnia and Serbia directly as well as via relevant local consultants

Key Responsibilities
  • Support enablement of Commercial Strategy 
  • Ensure compliance
  • Regulatory submissions and dossier preparation: Safety and
  • Pharmacovigilance/Vigilance
  • Internal Stakeholder Management:
  • External Relations and consultancy management:
  • Budget management: Manage and coordinate Regulatory/Safety budget preparation for the Adriatic countries

Person Specification

Education & experience required:

  • Educated to degree level within life sciences. 
  • Substantial experience (3+ years) 
  • Experience includes Medicines and Medical devices; with Medicines experience spanning new MAAs (with awareness of National Procedures/DCP/MRP), as well as management of line extensions and licence maintenance activities.
  • Experience with Traditional Herbal Medicinal Products, Biocides, Food Supplements, and Cosmetics would also be beneficial.
  • Involvement in the generation/review of product claims and advertising materials across product types.
  • Experience with Pharmacovigilance and materiovigilance systems
  • Fluent English

 

 

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.