New Jersey, New Jersey, United States
|Posted:||41 days ago|
|Location:||New Jersey, New Jersey, United States|
|Salary:||$50 - $65 per hour|
Xplore Life Sciences are recruiting for a Senior Regulatory Affairs Manager (Labelling) for work with a leading American Professional Services Company within the Clinical Domain.
Location will be fully remote with offices also located in Paddington, London.
You must have valid right to work in the UK
- Monitor and develop continuous improvement proposals on the processes
- Maintain a staff of adequately skilled resources to meet deliverables
- Communicate issues and resolve them in an appropriate time frame
- Ensure adherence to agreed-to work practices
- Meet established submission timelines and quality standard.
- Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling
- Ensure collection of metrics
- Improve speed to minimize the cost
- Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
- Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
- Must be able to construct a Company Response (MAH response) for health authority questions
- Masters in Life Sciences
- Understanding of key regulatory and Labeling principles and SOPs
- Should be open to work in any shift as per the business requirement
- 6-9 years’ experience in Regulatory affairs
- Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.
- Marketing authorization experience.
- Proven Project Management experience