Senior Regulatory Affairs Manager CMC (INDs/IMPDs)

Project-ID: 1583

Ihr Aufgabengebiet

Preparation of CMC-related submission documents (Modules 3 and 2.3) in compliance with current regulatory standards in support of clinical trial applications (e.g., INDs, CTAs) and applications for marketing of new drugs (e.g., NDA, MAA)
Preparation of CMC sections of briefing documents, responses to health authority inquiries, expedited designation applications, applications to obtain orphan drug designation, annual reports
Participation in and preparation of Pre-IND and Scientific Advice meetings (CMC aspects).
Research, analyze, and interpret CMC regulatory information and determine acceptability of data, procedures, and other product-related documents submitted in support of product approval
Actively collaborate with development teams, technical teams (manufacturing, supply chain, etc.) and quality department to prepare and implement robust CMC submission strategies for development and regulatory approval
Provide CMC regulatory expertise to internal departments (including R&D, manufacturing, quality assurance, quality control, marketing and clinical affairs) and external partners
Contribute to the preparation of product information (EU/FDA).

Ihr Hintergrund

Successfully completed degree in pharmacy, chemistry, biochemistry, or biotechnology, a postgraduate degree would be an advantage
Solid experience with GMP regulations as well as regulatory requirements related to pharmaceuticals
5-10 years of experience in a regulatory CMC role
Independent and responsible approach to work
Experience in working with therapeutic antibodies, or diagnostic drugs would be an advantage, preferably in both areas
Very good written and spoken English, German language skills would be a plus
Methodical competence, assertiveness
Reliable and emphatic manner, team-oriented
Confident handling of the common MS-Office programs

Ihre Benefits

Family environment with plenty of room for development and creativity
Flexible working hours with working time recording and possibility to reduce overtime
High work-life balance, in particular good compatibility of family and career
Possibility to work almost exclusively remotely
Above-average compensation with many additional benefits (Christmas bonus, shares, company pension plan, training budget, etc.)

Gender-Hinweis

Aus Gründen der besseren Lesbarkeit wird auf die gleichzeitige Verwendung der Sprachformen männlich, weiblich und divers (m/w/d) verzichtet. Sämtliche Personenbezeichnungen gelten gleichermaßen für alle Geschlechter.

Vertragsart

Festanstellung

Branche

Pharmaceuticals

Fachbereich

Regulatory Affairs

Ort

remote

Deutschland

Starttermin

asap

Dauer

Unbefristet

Remote

Auslastung (FTE)

Ihr Ansprechpartner

Karoline Gutensohn

Executive Recruiting Managerin

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