Assistant Vice President - Global Pharma Labelling Strategist & Regulatory Affairs

Assistant Vice President - Global Pharma Labelling Strategist & Regulatory Affairs

This role is for a SME in Global Pharma labeling and would involve driving projects in the area of regulatory framework and implement solution and drive transformation for the client.

Responsibilities :

In this role, you will be responsible for all the activities related to:

- Monitoring and developing continuous improvement proposals on the processes.

- Maintain a staff of adequately skilled resources to meet deliverables.

- Communicate issues and resolve in an appropriate time-frame.

- Ensure adherence to agreed-to work practices.

- Meet established submission timelines and quality standards.

- Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling.

- Ensure collection of metrics required

- Maximize speed and minimize cost

- Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions.

- Guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. This may also include Regulatory Authority driven documents such as the Core Safety Profile.

- Ensure that client is up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles

- Project management to the Labeling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.

- Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.

Qualifications we seek in you!

Minimum qualifications:

- Masters in Lifesciences or equivalent with 15+ years of experience in regulatory Affairs/Global Pharma Labeling or equivalent

- 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

- Strong knowledge of key regulatory and Labeling principles and SOPs

- 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 presenting to senior management when required

- Must be able to construct a Company Response (MAH response) for health authority questions

- Previous strong client management experience required

Preferred Qualifications - Global Exposure