Functions as a Trainee CMC -Regulatory strategist responsible for the assigned CMC activities of medium complexity/risk related to clinical development programs with in Global - Brands under direct supervision and guidance. The responsibilities includes, but not limited to the following.
- Assist in gathering and interpreting global clinical submission CMC requirements using systems and/or in collaboration with country regulatory leads for the development of regulatory strategy
- May assist in authoring IND and IMPD CMC dossiers
- Author ROW IMPD CMC dossiers under supervision and in close collaboration with the CMC Lead and coordinate quality review according to internal procedures as well as sign-off procedures(Reg-456/459 reviews).
- Assist in collection of supporting documentation from Pharm Sci, PGS, etc. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Support CMC systems maintenance and publishing activities (e.g. SPA, PDM, etc)
- Liaise with RCM as needed
- May assist in the authoring of initial registration NDA/MMA and ROW CMC dossiers and submissions activities
- Support clinical CMC activities for the existing portfolio, e.g. CMC activities to support BE, pediatric development, etc
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects within a work team.
- Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
- Assess scientific opinions and assist in developing regulatory strategies and documentation.
- Recommend solutions for standard situations and escalates issues with significant business impact where necessary.
- Support team in the development of regulatory strategies to support registrations.
- Assist in the development of resolution proposals for moderate regulatory CMC/information management issues in support of project/program stakeholders.
- Updates ancillary document requests in appropriate system, as needed.
- Minimum - Postgraduate in Pharmacy or Science
- Minimum 0 - 2 years of CMC experience within a regulatory function with knowledge of INDs/IMPDs, NDAs, ANDAs, MAAs, CTDs and other regulatory components.
- Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in a matrixed environment. Attention to detail and accuracy required. The candidate ideally should have experience with effective teamwork, collaboration, and communication.
- Must be able to prioritize with guidance. Ability to handle multiple projects with good prioritization skills. Willingness to work flexible hours.
- Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects.
- Aware of external regulatory environment, including competitor intelligence and regulatory actions to assist regulatory strategy development.
- Ability to identify inconsistencies and deficiencies in technical data and escalates to management for resolution.
- Knowledge of drug development practice, rules, regulations, and guidelines.
- Demonstrates knowledge of key processes, procedures and tools.
- Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.
- Demonstrates a high level of integrity in decision making on regulatory issues in line with company values.
- Fosters a culture in which uncompromising integrity and accountability is the standard.
- Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
- Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.
Engineering & ConstructionFunctional Area:
Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category:
Drug Regulatory Affairs/DocumentationRole:
Drug Regulatory Affairs/DocumentationEmployement Type:
Any GraduatePost Graduation:
Ph.D/Doctorate in Chemical, Chemistry, Plastics