Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a integral CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Responsibilities
- Accountable for aligned markets for required regulatory in-scope ancillaries and samples
- Understand aligned markets regulatory ancillary requirements
- Manage aligned markets ancillary and samples requests are completed per agreed timelines in support of planned regulatory submissions
- Manage in a matrix environment with effective communication across multiple functions
- Escalate to Client and Contractor point of contact when timelines may not be reached.
- Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all users.
Minimum requirements
- 3+ years Regulatory experience
- Demonstrated ability to support international product approval
- Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
- Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
- Can demonstrate leadership and team skills.
- Advanced Microsoft Office Suite skills.
- Highly efficient communicator.
- Acts decisively and seizes accountability
- Bachelor’s degree Level (desirable or equivalent work experience.
- Familiarity with pharmaceutical organizational Structures.