The Senior Regulatory Affairs Scientist role is a technical specialist role within LATAM Region. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support.
The role interfaces 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.
The RA Scientist, LATAM 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.
The role will ensure high quality submissions and that all dossiers are up to date and compliant and that regulatory commitments are fulfilled.
The RA Senior Scientist, Regions may have direct reports who are co-located on site, and will be responsible for the planning and oversight of the work to be conducted by their reports, and for the on the job training and coaching of their reports.
The role will develop collaborative and respectful relationships with staff at National Human Medicines Regulatory Agencies within the region (e.
g. ANMAT, ANVISA, INVIMA, COFEPRIS) to build and maintain credibility for Seqirus, as related to their products / project.
Major Accountabilities :
Lead and assist in the formulation and implementation of the regulatory Strategy for Seqirus products in the region
Lead the preparation and submission of high quality applications in Seqirus territories including marketing authorisation applications, variations, renewals and responses to questions, in particular providing regional expertise for Module 1.
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
Deputise for Senior Manager / Region Head (as applicable) as required
And other job duties that may be assigned from time to time.
Minimum Requirements :
A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Masters or PhD, or complementary experience in the pharmaceutical / biotechnology industry.
3-5 years regulatory affairs experience with specific regulatory knowledge and experience in US / EU / Australia regulatory affairs.
Experience in biologicals preferred.
Effective verbal & written communication skills in a cross functional environment
Attention to detail
Excellent project management skills
Evidence of commercial awareness in regulatory strategies
Excellent customer focus with demonstrated management of customer expectations
Worker Type : Employee
Worker Sub Type : Regular