Regulatory Affairs Associate
Responsibilities:
- Drive global submission management activities for their assigned products. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with major submission development and execution for designated products and/or geographies.
- Key participant and member of development teams and relevant endgame committees, to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
- Monitoring activities relating to compliance dossiers triggered by document management systems as well as executing Quality Control checks of compliance dossiers, dispatch approved dossiers to agencies as appropriate.
- Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
- Ability to quickly learn and master technical submission building and management software, responding actively to required changes in regulatory guidance.
- Utilisation of submission forecasts to proactively plan submission workload and identify areas to support team members in times of higher workload.
- Coordination of team training and reporting tools to ensure overall team compliance.
- Publishing and performing technical validation (eCTD/CTD/NeeS/Paper)
- Performing final technical quality review.
- Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
- Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders
- Strong Interpersonal Skills (Excellent verbal and written Communication, Problem solving, coordination etc.)
- Flexible and adaptable to change with vision for process improvement
- Attention to detail
- Effective time management and organizational skills
- The ability to meet tight deadlines and client management skills
- Technically adept using IT systems and software (Microsoft Office)
- Fast learner with proven ability to quickly understand overall changing demands of Projects
- B. Pham/M.Pharm/Science Graduate/ Life Sciences or related field is must
- 1-3 years' experience in the Pharmaceutical Regulatory Industry/ Submission Management/ Publishing / eTCD
- Clinical research experience is desirable