Regulatory Affairs · Barcelona · Fully Remote
CMC Expert (Biologics) Do you want to join us as CMC Expert and boost your skills in a Global technical environment? Are you willing to contribute, learn and develop? Do you want to apply your knowledge in health sciences and RA in a dynamic and international team?
Main responsibilities: • CMC project lead/responsible person, reporting to CMC Director.
• Overall CMC writing/management of product-specific dossiers (Mod. 2/Mod. 3), including, but not limited to, new registration packages, variation packages and renewal packages in the EU, US and RoW markets.
• High-quality strategic support to CMC roadmaps, dossier sections are responses to deficiency letters (including coordination and preparation of responses to questions).
• RA CMC Change Control assessment/management, when required.
• RA CMC liaison person with clinical and non-clinical teams, RA lifecycle management teams, tech/subject matter experts, QA, QC, Production and Supply, as per project needs.
• Establishing and improving processes and work instructions.
• Responsible for achieving deadlines, working towards first-time quality, to ensure client satisfaction.
• Preparation of and participation as a speaker on team-related training, both internal and external.
• Mentoring and coaching junior staff in project teams.
• Support in business development and marketing activities.
Requirements: •+4 years experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required.
•Background in Health Sciences, preferably biochemistry, biotechnology, biomedicine and related careers.
•Experience in Biological products will be a plus.
•Good analytical, quality-oriented, and customer-focused skills.
•High level of English and Spanish
•Willing to learn and take on new challenges and responsibilities
•Good team player with good communication skills
•Ability to handle multiple tasks/projects in a fast-paced environment
•Truckloads of motivation, positivity, and enthusiasm.
We offer you: A highly, dynamic & international working environment with employees from more than 15 nationalities.
A professional, inclusive and high-performance work environment to develop your skills and grow your career.
A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
Training and personal development program.
Flexible working schedule - Compacted workday on Friday.
Home Office - Hybrid or Remote Model (BCN and Madrid Offices but you can be located anywhere in Spain!) Our employees´ health, safety and well-being are paramount to us.
We are a close organization in an environment of transparent communication. We offerdiversified opportunities and continuous professional growth. You will have the opportunity to integrate in a dynamic team of international scientific prestige and to workin innovative projects. About Asphalion ASPHALION is an international Regulatory & Scientific Consulting in Life Sciences with offices in Barcelona, Madrid, Munich and London. Founded in 2000, ASPHALION has grown consistently and currently employs more than170 team members of over 16 different nationalities.
Founded in 2000
Co-workers 170
Regulatory Affairs · Barcelona · Fully Remote
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