Cmc Expert

hace 3 semanas

Barcelona, España Asphalion A tiempo completo

**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.
- 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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