Director Regulatory Affairs

Essential Functions:

• Includes preparing and maintaining the CMC documentation for peptide and oligonucleotide drug substances for different applications as NDAs, DMFs, CEPs, INDs etc.
• Knowledge of FDA, EMA and other global agencies’ regulations related to CMC submissions for generics and NCEs
• Will be expected to work "hands-on" with relevant tasks as required (i.e., writing technical/regulatory texts and being in dialogue with appropriate regulatory authorities).
• Represent the US Sites Regulatory Departments, internally and externally and will work with Regulatory Affairs at other sites and Global Functions for continuous improvements.
• Lead, organize and develop the department’s work, and establish, follow-up on objectives, both individually and for the team, while setting priorities, quality standards and managing the budget.
• Perform other related duties as required and assigned.

Job Requirements:

• Minimum bachelor’s degree in chemistry, Biochemistry, Pharmaceutical or other related sciences
• Must have 5-7 years of experience working with, or close to, Regulatory Affairs CMC combined with relevant work experience.
• Must have people management experience.