Cmc Expert - Barcelona, España - Asphalion

Asphalion
Asphalion
Empresa verificada
Barcelona, España

hace 4 semanas

Isabel García

Publicado por:

Isabel García

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Descripción

Main responsibilities:


  • CMC project lead/responsible person, reporting to CMC Director.
  • Overall CMC writing/management of productspecific 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.
  • Highquality 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.
  • Independent CMC project management.
  • Successful client management.
  • Establishing and improving processes and work instructions.
  • Responsible for achieving deadlines, working towards firsttime quality, to ensure client satisfaction.
  • Preparation of and participation as a speaker on teamrelated 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, qualityoriented, and customerfocused 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 fastpaced 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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