Heidelberg + Homeoffice: Regulatory Affairs Manager – OTC (m/w/d)

An exciting opportunity has arisen to work for an international company, with a very successful product portfolio, in the field of PHARMA – OTC.
For the office located in Heidelberg (in combination with 40% homeoffice) we are searching for a:

Regulatory Affairs Manager (m/f/d)

 We offer:

• Extensive training and a very friendly team
• Above average salary and benefits package
• Opportunities for personal and professional growth
• Great flexibility incl. 40% homeoffice
• Excellent working conditions

Your tasks:

• Assessing Regulatory strategies
• Providing Regulatory input into portfolio discussion and pipeline discussion
• Filing and follow up of applications for MAs, variations, PSURs and other regulatory actions, ensuring timelines are kept
• Artwork and copy approval from Regulatory perspective including recommendation for further improvement
• Active participation in life cycle management considering regulatory and business needs while paying attention to cost aspects
• Independently managing assigned projects
• Ensuring smooth business processes by preventing disruptions due to regulatory aspects
• Supporting the development of Regulatory claims
• Supporting brand development from Regulatory Affairs perspective
• Managing requests of authorities
• Taking ownership of assigned projects
• represent Regulatory function as leading and knowledgeable partner in business development
• Enhancing Regulatory knowledge within the team by providing learnings from own projects which are applicable to other brands
• Conducting tasks as a business partner and owner of the product from Regulator perspective

Profile:

• Experience in Drug Reg Affairs
• Degree in natural sciences, Pharmacy or Medicine
• Experience in all types of application for Marketing Authorisations
• Experienced with Licence Maintenance & Life Cycle Management
• Very good communication skills (in order to transfer regulatory knowledge to non-regulatory audience)
• Fluency in English and German

Do you want to know more about this position? Contact:

Silvio Di Meglio

Tel.: 0049-(0)89-80913072-1

dimeglio@triga-consulting.de