Description |
Specific Responsibilities: The successful applicant will have previous, direct regulatory experience with development projects at End of Phase 2 and Phase 3 and be willing to lead all regulatory activities for assigned project(s) and territories in line with ICH guidelines, regional requirements and scientific excellence and company policies and procedures. Recent experience with preparation of original INDs in eCTD format is desirable but not essential.
This person should be capable of representing the Regulatory Function at internal meetings and to clearly and persuasively articulate the regulatory risks and benefits of alternative strategies to facilitate rigorous, team-based decision-making. While the professional's previous experience may have been concentrated within a single Regulatory Region e.g. US, they should have a working knowledge of key regulatory aspects of clinical trial and marketing authorization processes in other regions, e.g. EU, Japan and Canada. A significant proportion of this person's time will be dedicated to directing and managing content development of technically complex submissions; this will require extensive interaction with both matrix and line management. The applicant should be able to review protocols, reports, summaries and Investigator's Brochures with a critical, balanced eye and recognize opportunities for efficiencies in submission preparation throughout the product lifecycle. An understanding of regulatory intelligence resources and current knowledge of the regulatory environment is expected. Previous experience within the gastro-intestinal, anti-inflammatory or antiviral disease areas is highly desirable.
Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities. Excellent influencing and negotiation skills. Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments. Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses. Work is performed under consultative direction towards corporate regulatory goals and objectives. Schedules and arranges own activities and those of direct report(s) (if applicable). Is recognized as an expert resource for Regulatory Advice in other departments.
Essential Duties and Job Functions: Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories. Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories. Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Acts as project team representative and may act as submission team representative for specified products. Represents Regulatory Function at internal meetings. Works proactively to build contacts with local Regulatory Authorities. Participates in industry trade groups and regulatory affairs professional societies. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management. Initiates or contributes to local and / or global process improvements which have a significant impact on the business
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Requirements |
Knowledge, Experience and Skills:
Typically requires a BA degree in a relevant discipline and minimum 10 years of relevant experience in regulatory affairs. An advanced degree is desirable. Previous people management experience and direct experience working with Regulatory Authorities in assigned territories is required.
Experience representing Regulatory Affairs on project teams is mandatory. Excellent verbal, written, negotiation and interpersonal communication skills are required. Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
When applying, please specify "LatPro.com - position title" at the top of your resume.
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