As a Regulatory Affairs Specialist within Keyrus Biopharma, you will join a team on client's site to develop and execute strategies for new products and across product life cycles.
As the position holder, you will:
Manage submissions and interactions with the EU regulatory agencies;
Troubleshoot and resolve any problem on the critical path to product registration;
Provide regulatory support, guidance and expertise to internal groups to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed in compliance with appropriate regulations and guidelines;
Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives;
Manage centralized procedures, work in conjunction with regional subsidiary staff for decentralized procedures and provide critical assistance for national submissions in the above-mentioned region.
Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of new drug applications, and post-approval submissions in the EEA, Switzerland and non-EU CES countries;
For assigned development and/or marketed products, lead cross-functional Teams as appropriate;
Work with project teams and department management to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval. Ensure regulatory strategies are aligned with project teams and business objectives and deliverables;
Ensure regulatory milestones for assigned projects are met;
Serve as principal regulatory contact with regulatory agencies and HQ/affiliates;
Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams. Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements;
Communicate new regulations and standards which may affect products to other regional colleagues to ensure any broader impact to the organization is also fully understood;
Educate, train, and advise company professionals to ensure appropriate compliance with internal and external processes and procedures;
Maintain a thorough knowledge of specific diseases within therapeutic areas assigned; including a detailed understanding of the prevailing attitudes and the practices in each country toward those diseases and their treatment;
Attend appropriate outside meetings and courses to maintain competency and awareness in his/her product area, international regulatory activities, and the pharmaceutical industry at large;
In all daily activities, adhere to client's leadership and compliance standards.
Education & Experience:
Master degree or PhD in a related field (Pharmacy, Life Sciences);
At least 5 years of experience in clinical research or regulatory affairs is required.
Demonstrated competence in biomedical research gained through appropriate experience of 3-4 years;
Possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered;
Knowledge/experience of EU regulations, guidelines and regulatory processes for products in development and in life-cycle maintenance;
Fluent written and spoken English is required.
Outstanding, interpersonal, written and oral communication skills;
Outstanding collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment;
Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities;
Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills;
Ability to work independently with minimal supervision to perform job function;
Ability to work in cross-functional and international environment;
Detail- and goal-oriented;
Quality conscientious and customer-focused;
Ability to adhere to strict project timelines;
Strong team player;
Good judgment and problem solving skills with ability to identify, analyze, and resolve problems in a timely manner.