Senior Scientist, Regulatory Affairs, Latam

Please present resumes in English

**The Opportunity**

You will be a technical specialist within LATAM Region and will have the opportunity to shae the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support.

You will partner with other functions in Regulatory Affairs (e.g. Global Regulatory Leads, Global Labelling, Regulatory CMC & Compliance, Regulatory Operations & Compliance,) and across the organization in Commercial Operations and Business Development, to ensure collaborative connectivity with these key stakeholders, and a focused regulatory approach to supporting country and regional business objectives, or global R&D objectives.

You will contribute to the implementation of global & regional objectives by leading and executing the regional strategy for one or more products under the direction of Senior RA Managers or the Region head. Your role will ensure high quality submissions and that all dossiers are up to date and compliant and that regulatory commitments are fulfilled.

You will develop collaborative and respectful relationships with staff at the regulatory agencies in LATAM (ANMAT, etc.) to build and maintain credibility for Seqirus, as related to their products/project.

Serve as Co-Technical Director for the Seqirus affiliate in Argentina.

**The Role**
- Lead and assist in the formulation and implementation of the Regulatory Strategy for Seqirus products in the region
- In collaboration with Global Strategic Labelling lead the maintenance of up-to-date product labelling for Seqirus products in the region (PI, CMI, SmPC, PIL etc)
- Provide regional expertise to global regulatory functions to ensure dossiers meet content requirements for applicable territories
- Contribute specialist regional advice for global regulatory strategy development, especially for product development programs and complex technical changes
- Establish and maintain strong and collaborative working relationships with assessors in Regions National Regulatory Agencies
- Contribute to the global regulatory intelligence database as required and support the drafting of company position statements and responses to pending changes to regulatory legislation, Regulatory Agency Discussion Papers/White Papers.
- Actively contribute to the global Seqirus regulatory community through designated projects.
- Contribute to the growth and professional development of assigned mentees, assist manager in the training and development of less experienced staff
- Contribute to the development of the budget preparation and resource planning, and monitor progress for product(s)/ projects

**Your skills and experience**
- Fluency in Spanish & English is required
- A degree in Pharmacy; preferably with a Masters or PhD, and complementary experience in the pharmaceutical/ biotechnology industry.
- 3-5 years regulatory affairs experience with specific regulatory knowledge and experience in regulatory affairs in Argentina and/or other LATAM countries.
- Experience in biologicals preferred.

**Our Benefits**

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

**About Seqirus**

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

**We want Seqirus to reflect the world around us**

As a global organization with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

**Do work that matters at Seqirus**

**Our Benefits**:
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

**About Seqirus**:
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

**We want Seqirus to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at Seqirus.

**Do work that matters at Seqirus**:
**Watch our ‘On the Front Line’ video to learn more about Seqirus