Senior Specialist, Regulatory Affairs

biosimilars-right.eu

Not specified; varies by local market; not specifi...
Licensed pharmacist required
Fluent in english and local language
Minimum 5 years industry experience
The Senior Specialist acts as a Poison License A Holder and ensures full compliance with global and local SOPs while managing regulatory submissions

Job Summary

  • The Senior Specialist acts as a Poison License A Holder and ensures full compliance with global and local SOPs while managing regulatory submissions.
  • This role involves developing product registration strategies and collaborating cross-functionally to review plans with management oversight.
  • Organon is a $6.5 billion global healthcare company focused on women's health and biosimilars with a vision for a healthier every day.

Matching Summary

The Senior Specialist acts as a Poison License A Holder and ensures full compliance with global and local SOPs while managing regulatory submissions.

Salary

Not specified; Varies by local market; Not specified

Skills & Requirements

Must-have

  • Licensed Pharmacist required
  • Fluent in English and local language
  • Minimum 5 years industry experience
  • Expert knowledge of local RA regulations
  • Ability to manage post-market regulatory dossiers

Nice-to-have

  • Cross-functional collaboration skills
  • Process improvement mindset
  • Strong time management abilities
  • Proactive problem solving approach
  • Experience with drug shortage management

Key Requirements

  • Licensed Pharmacist degree
  • 5+ years Regulatory Affairs experience
  • Fluency in English and local language
  • Expertise in assigned country RA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter