Description
This role involves line management responsibilities for a team of Regulatory staff and may involve overseeing one or more Regulatory Affairs sites.
Key Responsibilities:
- Manage staff in accordance with organisational policies and applicable regulations
- Develop regulatory business in line with Global Regulatory Affairs plans
- Coordinate projects and resources to ensure quality deliverables
- Set and implement site-specific objectives and business strategy
- Build strong relationships with other operations managers
- Provide strategic regulatory and technical consultancy on projects
- Manage meetings with Regulatory Agencies and write/review regulatory proposals
- Lead process improvements and problem-solving
Requirements:
- Bachelor's or Master's degree in Life Sciences or related discipline
- At least 6 years of regulatory experience, including 3 years of management experience
- Specific regulatory or technical expertise
- Strong interpersonal and communication skills
- Software and computer skills, including Microsoft Office applications
- Negotiation and decision-making skills
- Ability to work on multiple projects and retain quality and timelines
Benefits:
- Competitive salary ($103,600 - $288,600 per year)
- Incentive plans, bonuses, and other forms of compensation may be offered
- Range of health and welfare benefits
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