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Job Description
Regulatory Senior Scientist
A global pharmaceutical company seeks a skilled Regulatory Senior Scientist to lead global marketing authorization submission management processes.
Key Responsibilities:
- Lead global marketing authorization submission management processes for Drug Substance and Drug Product.
- Manage submission content, including structure and content placement within CTD registration submissions.
- Collaborate with regulatory scientists to manage outsourcing activities and contract manufacturers.
- Develop and execute regulatory strategies to support product submissions.
- Prepare CMC CTD content consistent with approved manufacturing changes and procedural requirements.
- Manage submission timelines, monitor approval status, and communicate change status to relevant teams.
Requirements:
- Minimum degree in Life Sciences, ideally an advanced degree (MSc, PhD, PharmD).
- Regulatory experience in a pharmaceutical or biotech environment.
- Knowledge of regulatory and compliance guidelines in pharma/biopharma.
- Knowledge of Manufacturing and Quality work processes and GMP compliance.
- Proven ability to effectively influence within a team.
- Excellent verbal and written communication skills.
- Fully proficient in RIM and common Microsoft applications.
- Good organizational skills, with the ability to prioritize and be self-motivating.