Sr. Director, Regulatory Affairs Ssdm Regional Hub
il y a 2 semaines
The RA Shared Service Delivery Model (SSDM) Regional Hub Lead is accountable for the delivery of all regulatory milestones related with strategy, planning, development, submission, registration, approval, and life cycle maintenance of Pharmaceutical Products Registration in compliance with our company standards and local applicable regulations associated with template submissions, submission enablement and Labeling and Artwork workstreams from a global perspective.
This position will manage a team of regulatory professionals at various levels of the organization and will required enterprise-wide collaboration with external and internal partners within our Research & Development Division and our Manufacturing Division.
Main Responsibilities:
- Provide regulatory leadership, expertise and guidance, as needed, to the various SSDM Hub workstreams to ensure seamless continuity for quality and timely delivery of deliverables
- Where necessary, lead the development, communication, lifecycle management and review of regulatory strategy/documentation for projects assigned within SSDM
- Develop and assist in the Global Strategic Plan and provide appropriate input into the product's Global Strategic Plan for continuous improvement within the SSDM workstreams
- Manage the team's execution of documentation for all assigned work within SSDM associated with the 3 workstreams per the established business processes and systems
- Obtain input from various members within GRACS to develop a global regulatory strategy which supports product development, registration, and lifecycle maintenance for the work assigned within SSDM
- Conduct al activities with an unwavering focus on compliance
- Identify and communicate potential regulatory risks and develop/communicate mitigation approaches for SSDM activities the team is accountable for
- Demonstrate superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills
- Demonstrate ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
- Demonstrate flexibility in responding to changing priorities or dealing with unexpected events
- Demonstrate sound understanding of related fields within regulatory (e.g., CMC, labeling, general regulatory, quality assurance, etc) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- Demonstrate effective leadership, decision making, communication, interpersonal and negotiating skills
- As needed, support the strategy and tactic deployment of priorities within the LATAM, EMEA and APAC Clusters
- Represent regulatory on product team and other key commercialization governance bodies as necessary. May serve as Regulatory representative in the steering committees and Medical Governance, among other executive meetings as required
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
Domestic/International
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Specified
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Requisition ID:
R263399
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