Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories.
Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Responsible for submitting, or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations, for assigned product(s) and territories.
Responsible for ensuring any updates to the CCSI and CCDS are implemented for assigned products in assigned territories in a timely manner.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories.
Represents the Regulatory Function at internal and external meetings.
Works proactively to build contacts with local Regulatory Authorities and participates in industry trade groups and regulatory affairs professional societies, as required.
Maintains knowledge of regulatory requirements, contributes to preparation of new regulatory guidance wherever possible, and communicates changes in regulatory information to project teams and senior management in a timely manner.
Deputizes effectively and reliably for Executive Director International Regulatory Affairs within the Company and with Regulatory Authorities.
Develops and implements training of Regulatory Affairs staff and other R&D staff as required.
Initiates or contributes to global process improvements which have a significant impact on the business.
Excellent verbal, written, communication skills and demonstration of excellent interpersonal skills are required.
Must be well versed in regulatory requirements, including ICH requirements and regional requirements for assigned territories, and have an astute understanding of current global and regional trends in Regulatory Affairs, and ability to assess the impact of these requirements on the business.
Must have a demonstrated understanding of business needs, and a proven ability to consistently assess resource requirements, and manage staff recruitment.
Must have a proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities and demonstrate a proven track record of excellent influencing and negotiating skills.
Excellent leadership and people management skills, in terms of management of workload and training and development of members of the team are required, as well as directing others in accomplishing objectives.
Must have excellent organisation skills and ability to ensure a multitude of tasks are appropriately delegated, managed and completed.
Must demonstrate the ability to lead Regulatory and Company teams, in preparation of submissions and maintenance of licenses, (via direct reports or matrix management).
Must have a demonstrable creative approach to solving problems, developing new procedures/working practices to facilitate management of work.
Must have significant cross-functional team experience including but not limited to interactions with Medical Affairs, Commercial and Market Access.
Experience in the review of promotional material, including promotional material for both national and international marketing congresses is desirable.
Demonstrated ability to work autonomously and reliably towards corporate regulatory goals and objectives agreed with manager, and is well recognised within the Company as an expert in regulatory advice.
Specific Education and Experience Requirements
Requires a Bachelor's degree in a relevant discipline (an advanced degree is highly desirable), with at least 8 years of Regulatory Affairs experience.
Oncology/biotechnology research or drug development experience highly desirable.
Previous people management experience in a Regulatory Affairs environment.
Experience working with Regulatory Authorities in assigned territories is required.
Experience representing Regulatory Affairs at Agency Meetings is mandatory.
The ideal candidate will align with the company’s core values by being accountable for their work, displaying integrity in everything they do, thriving in a team environment, seeing excellence as the only measure of success, and ensuring inclusion of all viewpoints in decision making.