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Details
Associate Director Global Regulatory Affairs
Reference: | SCA014363 | Location: |
Cork |
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Manager, Regulatory Affairs Specialist
Associate Director Global Regulatory Affairs
Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.
Responsibilities:
People Management:
- Recruit, develop, and retain a diverse and highly capable workforce
- Ensure robust individual training plans and timely completion of required training for direct reports
- Support and enable talent identification and career development that reflects an end-to-end mindsetand demonstrates judgement-based decision making
- Actively coach and mentor staff, including providing strategic guidance to staff on regulatory andlabelling process questions
- Empower staff members to make logical decisions, resolve issues and execute tasks
- Manage workload based on portfolio prioritization and address implications to overall resourcemanagement and strategies
- Support and encourage a culture of innovation and model inclusivity to ensure diverse voices andideas are heard and considered
- Provide mentorship for the managers in the team and across the site
- Align regulatory/labelling strategy with molecule team priorities
- Actively seek out information on the needs of internal and external customers and monitor US andCanadian regulations
- Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and incompliance with regulatory and quality system requirements
- Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution
- Utilize regulatory and process knowledge to drive decision-making
- Partner with quality in both process improvements and deviation management
- Provide strategic guidance to staff on regulatory process questions
- Monitor regulations and the external environment as appropriate
- Provide technical, administrative and operational support for regulatory and labelling-related systems
- Bachelor’s Degree, preferably in a scientific or health-related field
- Previous experience, preferably 5 years in a lead role in the pharmaceutical industry
- Must understand regulatory processes and the interdependencies of various tasks that requirecoordination among cross-functional team members and possibly third parties
- Experienced people manager
- Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspireothers
- Demonstrated flexibility and strong negotiation skills
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose rootcauses and take corrective actions to prevent reoccurrence
- Proven ability to coach and develop others
For more information please contact Sinéad Cullen on +353879500821 or [email protected]
Cork Product Development Engineer IT Packaging Engineer Academic Life Science Cork City Quality Engineering Connected Health Manufacturing Executive Validation Engineer Mayo Supply Chain Sales and Marketing Quality Control Laboratory Scientist Sales and Marketing Supply Chain Diagnostics Project Manager Medical Affairs Scientific Biotechnology Engineering Chemistry Pharma Sales Academic Medical Device Microbiology Dublin PhD Clinical Research Pharmaceutical Biopharmaceutical Allied Healthcare Scientist Quality Assurance Limerick
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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