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Position: Hub Submission Manager (Regulatory Affairs)
Location: Chennai, Tamil Nadu, India
- Responsible and accountable for Submissions Management and delivery of regional and/or national regulatory dossiers to Worldwide Health Authorities.
- Lead and manage logistical and technical aspects associated with submission management, ensuring the development and delivery of regulatory dossiers (initial application, lifecycle updates, compliance, and maintenance) to Worldwide Health Authorities in line with the regulatory strategy.
- Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partnering with product teams and/or third-party partners, the incumbent will be responsible for project management of activities, in support of regional and national regulatory submissions component build and delivery.
- Delivering project-specific Pfizer electronic and paper regulatory submissions. Including coordination and execution of solutions that meet the unique requirements of each submission and national market, management of product delivery to regulatory agencies, and ensuring subsequent archival.
- Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements, and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.
- Actively participate in the definition, investigation, and implementation of national, regional, and global process efficiencies for paper and electronic submission execution, including the evaluation of current processes.
- Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at the local level.
- Contribute to effective forecasting and management of project-specific resources utilizing flexible resourcing, and global load-sharing as a normal business practice.
- Adhere to the appropriate use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
- Escalates, informs and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
- Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
Knowledge and Skills:
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
- Proven ability to embrace new technologies and drive their implementation
- Proven aptitude in project management and process re-design
Standards, Processes, and Policies
- Strong knowledge of the drug development process, regulatory affairs, and submissions management; demonstrating an understanding of regional and national regulatory filing guidelines and dossier requirements
- Strong understanding of the build and delivery of human health electronic and paper regulatory submissions and electronic review aids as defined by FDA, EMA, MHLW and ICH.
Behavioral/Any other Skills
- Excellent oral and written communication skills.
- Demonstrated business acumen; strong organizational management skills, the ability to manage multiple demands simultaneously; the ability to respond to tight timelines in a highly regulated environment
- Proven aptitude in project management and logistics
- Ability to work on multiple highly complex projects simultaneously; demonstrated attention to detail.
- Ability to operate seamlessly and influence across organizations.
- Ability to manage or deliver through others in a global operating model
- Ability to manage a significant and diverse portfolio of work with cross-site and line teams.
Experience: Minimum 3 – 5 years experience in the Pharmaceutical Industry
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