Senior Manager – Regulatory Affairs

Inviting applications for the role of Senior Manager- Regulatory Affairs!
In this role, you will be expected to work on deadlines, in a fairly high-pressure business
environment while being a good great teammate.
Responsibilities
.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 labelin
.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

Qualifications we seek in you!
Minimum qualifications
.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

Preferred qualifications
Should be open to work in any shift as per the business requirement