Regulatory Affairs Associate Director

Specific Responsibilities and skills for Position:

Provide regulatory strategic submission support for registrations to the Commercial & Access Emerging Markets
Continued support for new registrations and support ongoing post-approval maintenance activities in Emerging Markets
Provide CMC submissions support to the Africa Registrations General post-approval support to update licences with regard to supply
Support new CTA filings in ROW markets
Support preparation of new ROW modules for new products as required

Essential Duties and Job Functions:

Responsible for leading all CMC regulatory activities for assigned products across global markets in line with ICH requirements, regional requirements and scientific and company policies and procedures
Ensures responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories
Prepares submissions that are technically complex and require extensive interaction with departments/partners/distributors outside of CMC Regulatory Affairs
Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain marketing authorisations for assigned product(s) and territories
Represents the CMC Regulatory affairs function at internal meetings and externally in communications with external distributors and partners

Knowledge, Experience and Skills:

Excellent verbal, written, negotiation and interpersonal communication skills are required
Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business
Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities
Excellent influencing and negotiation skills
Must be capable of leading the preparation and finalisation of regulatory dossiers and managing the ongoing maintenance of existing product licenses
Work is performed under consultative direction towards corporate regulatory goals and objectives. Schedules and arranges own activities
Is recognised as an expert resource for CMC Regulatory Advice in other departments
Well versed and competent with regulatory documentation and submission management systems

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.