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Regulatory Affairs Cmc

vor 2 Wochen

Munich, Deutschland Stirling Q&R Ltd Vollzeit

**Position: Regulatory Affairs CMC**

**About the Company**:
A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence to global regulations.

**Responsibilities**:

- They will be responsible for guiding clients on regulatory CMC drug development and strategic planning, ensuring alignment with policies, regulations, and manufacturing guidelines.
- The role involves assisting clients in determining appropriate development strategies and regulatory submissions that comply with regulatory standards.
- Providing insights on the importance of regulatory strategy to expedite product market entry efficiently.
- Collaborating with internal teams to support the submission lifecycle of drug products, biologics, and vaccines.

**Requirements**:

- A minimum of 6 years of experience in Global Regulatory Affairs CMC for Biologics and Small Molecules is required.
- Proficiency in preparing and reviewing regulatory CMC documents is essential.
- In-depth knowledge of CMC drug development for both Drug Substance and Drug Product is necessary.
- Strong organizational skills to manage multiple regulatory tasks within specified timelines.
- Excellent communication skills in English.

**Benefits**:
**Job Types**: Full-time, Permanent

**Salary**: 55.000,00€ - 120.000,00€ per year

**Experience**:

- Small Molecules: 4 years (required)
- Regulatory CMC: 4 years (required)

Ability to Commute:

- München (required)

Ability to Relocate:

- München: Relocate before starting work (required)

Work Location: In person