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Job Description
Regulatory Senior Scientist sought to lead global marketing authorization submission management processes and provide regulatory support for existing Drug Substances and Drug Products.
Our client, a global pharma company, is currently recruiting for a permanent position.
Key Responsibilities:
- Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining regulatory submission documentation.
- Partner with CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers.
- Ensure successful preparation of CMC dossiers and variation packages to support product submissions.
- Develop, plan, and execute regulatory strategies and priorities through effective partnership with CMC Regulatory Scientists and other functional representatives.
- Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
- Manage submission timelines with relevant teams and communicate change status to interested personnel in a timely manner.
- Partner with CMC Regulatory Associates to effectively support product lifecycle maintenance.
- Manage authoring and content reviews of regulatory documents.
Requirements:
- Minimum degree in Life Sciences, ideally an advanced degree (MSc, Ph D, Pharm D preferred).
- Regulatory experience in either a pharmaceutical or biotech environment.
- Knowledge of regulatory and compliance guidelines in pharma/biopharma.
- Knowledge of Manufacturing and Quality work processes as well as GMP compliance.
- Proven ability to effectively influence within a team.
- Excellent verbal and written communication skills.
- Fully proficient in RIM and in using common Microsoft applications.
- Good organizational skills, with the ability to prioritize and be self-motivating.