Scientific & Regulatory Affairs Officer

Scientific and regulatory affairs officer

Scientific & Regulatory Affairs Officer

Our team in Barcelona is growing!

Our team’s mission is our passion: to work together with our clients to generate ideas and implement solutions that contribute to better health in all our lives.

Do you want to be a part of this project and to be in contact with regulatory affairs departments and health authorities? This is your opportunity!

 

Purpose of the role:

We are looking for a Scientific & Regulatory Affairs Officer for our writing unit with experience within pharmaceutical industry, someone who loves to take new challenges, to work in an international environment and who wants to grow with us.

 

Scientific & Regulatory Affairs Officer Main Responsibilities:

The Scientific & Regulatory Affairs Officer for out writing unit will be in charge of the timely and correct execution of projects according to defined timelines:

  • Strategic Scientific & Regulatory Advise
  • Preparations of Non-Clinical and Clinical Modules ( 2.4, 2.5, 2.6, 2.7)
  • Non-Clinical and Clinical Road Map
  • IMPD, SA, Submission /Management CTA,
  • PIP, ODD
  • Biotech Projects
  • Medical Writing Sales activities
  • Training on Medical Writing topics
  • Request Health Authorities
  • Due Diligence and Road Map

 

Requirements:

  • Degree in Life Sciences
  • At least 2-3 years’ experience in Scientific Writing & Regulatory Affairs
  • Experience working in pharmaceutical industry.
  • Fluent in English & Spanish
  • Proactive, good communication, good scientifi and writing skills.

 

We offer you:

  • A highly professional, dynamic, ambitious & international working environment.
  • An organization with highly professional people to develop with.
  • More than 12 nationalities!
  • A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
  • Amazing views of Barcelona from the offices! // Home Office.
  • Training and personal development program.
  • Flexible working schedule. We enjoy Friday afternoon.
  • Social Benefits: English lessons/ Flexible remuneration.
  • Permanent contract
Business Developer - Regulatory Affairs