Cmc Expert (Biologics) Regulatory Affairs · Barcelona ·

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.
• Independent CMC project management.
• Successful client management.
• 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.
•Microsoft Office independent user level.
•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.
Social Benefits: English lessons, wellbeing programme, flexible remuneration.
Home Office - Hybrid or Remote Model (BCN and Madrid Offices but you can be located anywhere in Spain!) Permanent contract.


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