Accessibility Links

Global Regulatory New Product Development Manager

  • Job type: Permanent
  • Location: Zürich
  • Salary: Negotiable
  • Job reference: 352513/001_1539181058
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 10/10/2018

A leading global pharmaceutical company is currently looking for a Global Regulatory New Product Development Manager to join their growing Regulatory Affairs team.

They are looking for an experienced regulatory affairs professional with experience in product development as well as a highly consultative approach. In this global role you will be leading different projects and teams in a cross functional environment.

Responsibilities:

  • Understand and evaluate a proposed product concept to provide the best possible product for the customer and increase Probability of Technical Success

  • Collaborate with New Product Value Analysis (NPVA), Research and Development Teams, and Global Marketing to develop and maintain draft launch labels (DLL)

  • Provide regulatory and technical overview of submissions (dossiers / non-CMC technical sections) pertaining to a product's approval

  • Develop and Design a creative Regulatory strategy for the organization

  • Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers

Candidate:

  • Minimum 7 years of regulatory and clinical experience ideally within Animal Health

  • Experience with Product Development

  • Experience with non-CMC submissions is highly wanted

  • Excellent English is a must

  • Exceptional influencing and communication skills

Similar jobs
Process Scientist
  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: US$110000 - US$135000 per year
  • Description Process Scientist A leading Clinical-Stage pharmaceutical company is looking to enhance their research team with the addition of another Process Scientist. Process Scientist | R&D Boston |
Regulatory Affairs Manager - UDI
  • Job type: Permanent
  • Location: Basel-Country
  • Salary: Negotiable
  • Description My client, a globally established start-up company in the medical device industry is looking for a Regulatory Affairs Manager to compliment their regulatory team.
Ph.D. Method Development Scientist
  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Description Sr. Method Development Scientist Needed for growing Pharmaceutical Company Analytical Chemistry Boston, MA Salary: $85,000 - $105,000 + 10% Bonus A rapidly growing
Senior Scientist, CMC/Drug Product
  • Job type: Contract
  • Location: San Francisco, California
  • Salary: Competitive
  • Description I'm working with a rapidly expanding biotech company located in South San Francisco, CA. They are looking to bring in a Senior Scientist, CMC/Drug Product on a contract-to-hire basis
QC Analyst I
  • Job type: Contract
  • Location: South San Francisco, California
  • Salary: Competitive
  • Description Title: QC Analyst I Company Summary An advancing biotech company in South San Francisco is looking to bring on a QC Analyst to join their manufacturing team, on a 1-year contract basis