Organisational Unit : Regulatory Affairs CMC Department Head Responsibilities : - Define and manage the regulatory CMC strategies, timelines and policies, keeping the relationship with the technical departments in order to obtain the best results and coordinating the activities;
Manage, promote and circulate the CMC regulatory requirements and information on projects / products; - Ensure that the quality data package from technical departments is fully integrated in the regulatory quality parts of CTA : IMPD / IND / M3;
Ensure that all regulatory quality documents submitted to RA are scientifically accurate, of high quality, in regulatory compliance.
Activities : - Attendance to meetings : R&D Extended Technical Project Teams;- Provide to project teams and GRA executives, CMC counseling and expertise in the formulation and execution of CMC regulatory strategies with the development of actions for the optimization of drug development;
Accountable to draft and finalize the IMPD and IND Quality section or supporting clinical studies / clinical submission in development phase;
Accountable to draft M3;- Support, draft and review answers to the List of Questions during the regulatory assessment of IMPD and IND Quality section;
Support the GRA executives to set up the quality strategy and contents of BB for SA, OMPD, PIP documents for the quality aspects;
Review of the CMC contents of these documents.Educational Background : Degree in Chemistry and Pharmaceutical Technology / Pharmacy / Chemistry / Biology / BiotechnologyPrevious Experiences : - 1 / 2 years’ experience in CMC technical Development with in-depth knowledge of drug development- 2 / 3 years’ experience in Regulatory-CMC related activitiesTechnical Skills : - Deep knowledge of the full drug development process;
Deep knowledge of drug laws and drug development guidances;- Ability to guide through quality regulatory requirements.Managerial Skills : - Networking- Communication- Strategic thinking- Teamwork- Openness and flexibility- Drive for results- Self-motivation- Stress management- Planning & organisingLanguages :
English - good knowledgeType of contract : Temporary (12 months)Place of work : Parma, Italy - possibility of home-working
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