Description
Regulatory Affairs/Regulatory Affairs Manager/Regulatory Submissions/Emerging Markets/Regulatory Bodies
An exciting and challenging opportunity has arisen for a 6 month contract for a Regulatory Affairs Manager within the Anti-infectives & Respiratory therapy areas with a Global Pharmaceutical company. The role will be responsible for managing regulatory activities in markets outside of the EU, by maintaining existing anti-fungal licenses in the ROW region, and leading new licence applications in line with commercial priorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
*Preparation and/or coordination of designated regulatory submissions for marketed products in international territories outside of the EU, in line with Corporate objectives. These submissions may include, but are not restricted to, new license applications, renewals, labelling updates and variations.
*Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
*Liaises with company affiliates and/or third parties to co-ordinate translational activities and the subsequent submission of language versions to health authorities.
*Set and communicate regulatory strategy to project teams for assigned products and articulate complex regulatory affairs issues
*Liaises with regulatory, manufacturing and other parties as appropriate, to ensure product packaging and associated information is updated and maintained in accordance with product licenses in international territories.
*Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals, in designated markets of responsibility.
*Proactively participates in regulatory team meetings and recognised as a knowledgeable resource of Regulatory Affairs in other departments.
*Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.
*Proactively participate in routine local process improvements, which have an impact on the working of the Regulatory Affairs function and contribute to departmental initiatives
May also be required to work on other projects/other therapeutic areas to meet the requirements of the business that includes but not limited to o product registration, clinical trial activities and maintenance in European/International markets.
*When necessary, act as back-up support for the regulatory liaison responsible for anti-fungal product licenses in European markets and the Associate Director as required.
KNOWLEDGE, EXPERIENCE AND SKILLS REQUIRED:
*Typically requires a Bachelor's degree in a relevant discipline (biological/life sciences, pharmacy or medicine)
*Proven significant experience in Regulatory Affairs.
*Experience in the preparation/submission of regulatory documentation to support post marketing activities in international markets.
*Direct experience working with Regulatory Authorities is desirable
*Excellent organisation skills and ability to multi-task in a fast paced environment on numerous projects within tight time lines
*Proven ability to prioritise and independently manage workload.
*Excellent verbal and written communication skills and interpersonal skills
*Demonstrable organisational and leadership skills
*A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions to tight time lines
*Must be able to facilitate effective interactions within International Regulatory, as well as with other departments and sites within the company; Clinical Research, Medical Affairs, Safety, Legal, Commercial Operations, affiliates, distributors and partners
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice.