Global Regulatory Affairs Associate, Fast Growing Dermatology Company

at  Stratpharma

Basel, bs, Switzerland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate02 Sep, 2024Not Specified02 Jun, 20243 year(s) or aboveRegulatory Affairs,Pharmaceutical Industry,Ema,Regulatory Requirements,Communication Skills,EnglishNoNo
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Description:

Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.
This is a highly successful company who have an impressive 200% year on year growth and are going through significant expansion. They currently have 8 products on the market but have a further 5 more products in development.
As a Global Regulatory Affairs Associate, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the global registration and approval process for Stratpharma’s products.

REQUIREMENTS

  • Minimum 3 years of experience in Regulatory Affairs within the Medical Device or Pharmaceutical industry
  • Strong knowledge of global regulatory requirements, including FDA, EMA, and other regional regulatory bodies
  • Experience with product registrations and submissions in multiple countries
  • Excellent written and verbal communication skills
  • Strong attention to detail and organizational skills
  • Ability to work independently and as part of a team
  • Bachelor’s degree in a relevant field, advanced degree preferred
  • Fluency in English, additional languages a plus

Responsibilities:

  • Manage and maintain product registrations and submissions for global markets
  • Prepare and review regulatory documentation and technical files
  • Communicate with regulatory agencies and authorities
  • Monitor and stay up-to-date on relevant regulatory changes and requirements
  • Contribute to the development and implementation of regulatory strategies
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements


REQUIREMENT SUMMARY

Min:3.0Max:8.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Relevant Field

Proficient

1

Basel, BS, Switzerland