FAQs
Where is the job location for the CMC Regulatory Affairs Associate Director position?
The job is located in Barcelona, Spain, with a hybrid work model requiring three days in the office and two days working from home.
What is the focus area for the CMC Regulatory Affairs Associate Director role?
The focus area includes support for the biologics technical area, encompassing both traditional and novel molecules.
What are the primary responsibilities of the CMC Regulatory Affairs Associate Director?
Responsibilities include devising regulatory strategies for biological entities, providing expertise to project teams, leading regulatory interactions with health authorities, and sharing knowledge within the CMC department.
What qualifications are required for this position?
A Bachelor’s degree in a science or technical field, knowledge of manufacturing and regulatory project management, a strong understanding of global regulatory affairs, and CMC experience with submissions for biologics drug substances and products are required.
Are there any preferred qualifications for the role?
Yes, an advanced degree in a science or technical field and CMC experience with submissions for antibody drug conjugates, radioconjugates, or bispecifics are preferred.
How does the CMC Regulatory Affairs Associate Director collaborate with other teams?
This role collaborates with cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams, and works with colleagues in marketing companies globally to ensure successful regulatory outcomes.
What level of experience is necessary for the CMC Regulatory Affairs Associate Director?
Candidates should have significant experience in regulatory affairs, particularly in the CMC field, with a proven track record of handling complex regulatory submissions.
Will the CMC Regulatory Affairs Associate Director be involved in coaching or mentoring?
Yes, the Associate Director is expected to actively share knowledge and participate in the coaching and mentoring of colleagues within the CMC Regulatory Affairs team.
What types of regulatory interactions will the Associate Director lead?
The Associate Director will lead project-driven regulatory interactions with health authorities such as the FDA and EMA, especially for CMC scientific advice.
Is there an emphasis on keeping up to date with regulatory changes?
Yes, staying updated with emerging global regulatory requirements is a crucial part of the role.