Manager, International Regulatory Affairs - United Kingdom
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SUMMARY Contributes to development of submission strategy for projects assigned Responsible for building regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing portfolio.
- Contributes to development of submission strategy for projects assigned
- Provides input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labeling in markets assigned
- Establish within country, cross-product submission plan in association with Global/Regional Regulatory Lead, Regulatory CMC, commercial, affiliates &/or marketing partners
- Creates Content Plans to allow publishing & timely dossier submission.
- Responsible for building quality regulatory dossiers. Works with other functions as necessary
- Act as contact person in RA EMEA for local partners & affiliates as required
- Lead the organisation in the preparation of answers to questions from regulatory authorities.
- Responsible for ensuring that our company fulfills Regulatory Authority commitments.
- Ability to lead complex regulatory submissions for assigned projects
- Responsible for tracking all activities & for accurate submission plans in eQRMS and communicating any emerging issues to stake holders in a timely manner.
- Ensures that copies of regulatory documents are archived appropriately
- Can identify when to escalate issues to line management & knows when to seek advice.
- Proposes process improvements to manager. Shares best practice involving International regulatory submissions.
- Good understanding of high level strategic issues & implications of Company Core Data Sheet & Regulatory CMC.
- Bachelor’s degree in a scientific discipline or equivalent
- Experience of leading International Regulatory Affairs (RA) submissions
- Strong understanding of International regulatory landscape & required approaches/strategies.
- In-depth knowledge of regulatory requirements for countries assigned and good working knowledge of requirements across International region
- Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
- Understands constitution of CTD modules; non-clinical, CMC, Clinical
- Understanding of commercial goals and strategy for International region
- Takes initiative for professional development & seeks opportunities to learn from others
- Communicates complex ideas effectively across a culturally diverse environment & with Regulatory Authorities when tasks have been delegated
- Communicates effectively with Regulatory Authorities when tasks have been delegated
- Ability to influence internal stakeholders
- Effective project manager. Delivers quality projects in accordance with timelines.
- Prioritizes tasks appropriately, coordinates the delivery of multiple projects
- Must be flexible & adaptable to changing project priorities & work assignments
- Displays a willingness to challenge the status quo & take calculated risks
- Understands contributions of other departments & external stakeholders
- Understands & utilizes knowledge of local regulations & business practices when working across cultures
- Ability to travel