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Job Description
Regulatory Senior Scientist sought to lead global marketing authorization submission management processes, manage submission content, and provide regulatory guidance.
Our client, a global pharma company, is currently recruiting for a Regulatory Senior Scientist to join their team on a permanent basis.
Key Responsibilities:
- Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate 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 appropriate regulatory strategies and on agreed-upon 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, monitor approval status, and communicate change status to interested personnel in a timely manner.
- Partner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product and site renewals, as well as license expiry, where applicable.
- Manage authoring and content reviews of simple Rt Qs.
- Review/Approve regulatory documents such as full and core CMC Dossiers, variation packages, post-approval commitments with health authorities, and answers to questions received from health authorities.
Requirements:
- Minimum degree in Life Sciences, ideally an advanced degree (MSc, Ph D, Pharm D preferred), in a related biological and life science field.
- 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.
- Communicate effectively, particularly with the view to influencing and developing in an international matrix environment, demonstrating a wider business perspective.
- Displays a conscientious attitude, and possesses excellent verbal and written communication skills.
- Fully proficient in RIM and in using common Microsoft applications to create and present work.
- Good organizational skills, with the ability to prioritize and be self-motivating.
- Work well collaboratively within a team, or as an individual contributor.
- Possesses excellent attention to detail and ability to effectively prioritize.
- Proven effective teamwork skills; able to adapt to diverse interpersonal situations.