Regulatory Intelligence Specialist Lead
hace 2 semanas
The Regulatory Intelligence and Analytics team at Ergomed is seeking a Senior Associate/Specialist to support the development of regulatory strategies and deliverables. This role involves liaising with internal stakeholders, external partners, and authorities to ensure compliance with project, corporate, and industry regulations.
Key Responsibilities:- Provide intelligence on regulatory requirements and contribute to the development of strategic plans, including the creation of Regulatory Management Plans, joint operating procedures, POAs, and core documents.
- Support the identification of issues and maintain awareness of allocated tasks and hours, promptly escalating any OoS.
- Provide administrative support to Business Development activities and foster professional working relationships with internal and external contacts.
- Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
- Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
- Previous regulatory experience within the pharmaceutical/CRO industry.
- Good planning and organizational skills, with strong written and verbal communication skills.
- Excellent self-motivation skills and ability to work in a fast-paced, deadline-oriented environment.
$80,000 - $110,000 per annum, depending on location and experience.
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