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Exceptional opportunity to join a leading CRO in the role of Associate Director, Regulatory Affairs.
The Associate Director, Regulatory Affairs will provide direct management and support to members of the Regulatory Affairs Strategic team ane will oversee/ensure all aspects of Regulatory Affairs are conducted in accordance with sponsors requirements. The job holder will also be responsible for all budgets and contracts in relation to their assigned projects.
Duties and Responsibilities
• To provide project specific regulatory services and co-ordination of these projects.
• To review and prepare regulatory submissions in Europe, South Africa and Pacific Rim.
• Provide regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products
• To serve as the sponsors “Executive” contact person for all issues including attendance at Regulatory Agency meetings and other Public Relation functions.
• To contribute to development & implementation of Global/European Regulatory function/plans
• To provide direct management, support and assistance to the Regulatory Affairs Managers and Executives.
• To be responsible for the hiring of new Regulatory Affairs Managers and Executives.
• To provide training and mentorship to Regulatory Affairs Managers and Executives through liaison with the Training Manager.
• To review revenue budgets and have a creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements.
• To identify and recognise out of scope activities in a contract in a timely manner and liaise with Bids & Contracts to follow through on all aspects of contract modification.
• To be responsible for development/review and management of performance metrics of each regulatory project.
• To ensure quality performance for projects managed in their group.
• To ensure compliance with relevant organizational and Regulatory Affairs Standard Operating Procedures and Working Practice Documents.
• To participate as required in project Hand Off meetings, Review Meetings and Project Team meetings
• To provide regulatory advice and training services for Regulatory Affairs in the company.
• To provide staff with up-to-date legislation and guidance as it becomes available.
• To assist business development and senior management in securing new business by making presentations to sponsors, developing and reviewing bids and proposals, and conducting contract negotiation through to closure with the sponsor and BD.
• To deputise for the Director, Regulatory Affairs and Medical Writing as necessary.
To apply for this pivotal role of Associate Director, Regulatory Affairs, you are likely to have a Bachelor’s or higher graduate degree (or equivalent) in a science related field and Regulatory Affairs training and experience in a certain area.
This should be coupled with:
• Broad industry regulatory affairs experience.
• Excellent knowledge of the European/ROW Regulatory Procedures, including both clinical trials and product licensing.
• Proven success in agency influencing and negotiation.
• Expert knowledge of ICH and regulatory guidelines in Europe/ROW
• Good in-depth knowledge in one of the specialist areas; preclinical, CMC, clinical.
• Ability to motivate and integrate teams and teach/mentor team members
• Ability to prioritize workload of Regulatory Affairs staff
• Ability to discipline and reward employees and perform timely, effective performance evaluations
• Excellent judgment and decision-making skills
• Good, effective organizational, planning and negotiation skills
• Proven ability to work effectively in a team
• Excellent interpersonal skills and problem solving ability
• Effective oral and written communication skills
• Ability to act as liaison with other Divisions where necessary (i.e. Clinical Supplies, QA, Clinical Operations, Data management, Biostatistics, Medical Writing, etc)
• Knowledge of budgeting and forecasting
• Good computer skills such as Word, Excel and Powerpoint
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