
Regulatory Compliance Manager
4 days ago
Karo Group is dedicated to providing exciting and challenging projects that impact customers and the industry.
As a leader in Global Regulatory Affairs, you will be responsible for managing resources effectively to drive the maintenance and development of Karo medicinal products.
Job Title: Team Lead Pharma Submissions & ComplianceKey Responsibilities:- Lead the Submissions & Compliance team, ensuring personnel have the necessary competence for their roles.
- Manage resources effectively to drive the maintenance and development of Karo medicinal products.
- Allocate tasks and oversee the management of Submissions & Compliance activities, including strategies, submission planning, and performance monitoring.
- Ensure compliance with artwork processes, eRIMS data system archiving, and relevant regulatory requirements.
- Coordinate Regulatory Intelligence and support local RA consultants to ensure adherence to local regulations.
- Serve as the primary contact for eCTD Publishing and collaborate with the Head of Global Regulatory Affairs on follow-up tasks.
- Develop and maintain a comprehensive understanding of existing and emerging regulations, standards, and guidance documents.
- Provide regulatory input to cross-functional teams and projects, ensuring timely and adequate planning, preparation, and submission of regulatory procedures.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Coordinate subsidiaries, partners, and consultants on applicable market(s) and ensure Product Information translations are up-to-date.
- University degree in Life Science or equivalent.
- Minimum 5 years of experience in Global Regulatory Affairs, preferably in a leadership role.
- Proven track record of formal or informal leadership qualities, variation management, and artwork maintenance.
- Experience with National procedure, DCP, and MRP within the European Union, as well as global RA experience.
- Strong working relationship with regulatory authorities and excellent communication skills.
- A competitive salary package and opportunities for growth and development.
- A flexible schedule and life-work balance.
- Exciting and challenging projects that impact customers and the industry.
- A positive work environment in a dynamic, international, and motivated team.
- Start-up spirit while being part of a large international organization with strong values.
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