Associate Director Cmc - Munich, Deutschland - Meet Recruitment

Meet Recruitment

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

85000 EUR EUR

Munich, Germany
Permanent
Meet partner today with a midsize and growing biotech who are dedicated to the development of novel therapeutics against acute and chronic diseases. They are stepping now from drug development into a commercial stage and are to build up a CMC department internally for the exciting upcoming times.

Right now the CMC activities are strongly outsourced and in this role you will a key POC for working with external consultants and agencies for regulatory submissions.

Associate Director CMC - Regulatory Affairs - Autonomous Project Management

Responsibilities:

Oversee CMC activities for biologics product development, ensuring compliance with regulatory requirements and guidelines
Lead the planning, preparation, and submission of CMC sections of regulatory dossiers (INDs, BLAs, MAAs) for biologics products
Collaborate crossfunctionally with Manufacturing and Quality teams, to provide strategic input on CMCrelated matters
Coordinate all activities with regulatory agencies, acting as main POC
Lead CMCrelated inspections and audits by regulatory authorities or partners, ensuring timely preparation and addressing any findings or observations.
Participate in technology transfer and process validation activities during product lifecycle management
Report directly into VP of Regulatory Affairs

Qualifications:

Degree in bioengineering, chemistry, biology or equivalent
A minimum of 5 years of industrial experience in biologics manufacturing with a strong focus on CMC/ Regulatory affairs
Hands on experience with writing, preparing CTD Modules/ BLA, MAA submissions
Excellent project management skills, with the ability to prioritize tasks, meet deadlines, and adapt to changing priorities in a fastpaced environment
Fluency in English, German is a plus

Hybrid model:
working at either around Munich or Jena area with 2-3 days a week of home-office possibility. Full remote negotiable