锦鲤求职岗位描述
岗位职责
Position Objectives
- Serve as the primary regulatory interface ensuring collaboration with key internal stakeholders to ensure successful planning and execution of the global regulatory strategy for assigned projects.
- Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
- Partners with regions/vendors to align on regulatory strategy in order to fulfil business objectives
Main Position Responsibilities
Main Task 1：
• Development and implementation of global regulatory strategies; ensures compliance with worldwide regulations
Specific Responsibilities：
- Lead GRTs towards the planning and execution of all regulatory agency submissions through clinical development phases to product licensure/approval worldwide and through Phase 4 for assigned projects.
- Responsible for the planning, co-ordination and review of regulatory submissions to ensure they are complete, accurate and consistent with project objectives.
- Monitor compliance with regulations by region; updating systems and tools that are needed to track and assess compliance
Main Task 2：
• Serve as regulatory interface to internal and external stakeholders
Specific Responsibilities：
- Create and maintain the Global Regulatory Strategic Plan (or equivalent)
- Provide input to clinical development plans in conjunction with matrix team members
- Coordinate communication with internal and external stakeholders, ensuring projects remain within scope, schedule, and defined timelines, in collaboration with counterparts from various functional departments
- Responsible for overseeing interactions with the FDA, EMA and other Regulatory Agencies, depending on the region (e.g. pre-IND-, EOP2-, pre-BLA/NDA-meetings, EMA Scientific Advices, EMA Oral Explanations, EMA-FDA Parallel Scientific Advice Meetings), represent the company and serve as point of contact with regulatory authorities, as applicable.
- Facilitate preparation and finalization of briefing books and contributes to preparation of summary documents.
- Responds to Health Authority requests with a strategic mindset to ensure business objectives are attained
Main Task 3：
• Incorporate latest regulatory knowledge towards development of clinical plans
Specific Responsibilities：
- Monitor and research regulatory intelligence, to bring innovative approaches to the cross functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans
- Share latest regulatory and clinical knowledge within RA department and to external stakeholders (e.g. global development teams)
- Collaborate with global development partners
Main Task 4：(Line Function Managers – Director/SD)
• Efficient People Management (Driving Performance, Developing People)
Specific Responsibilities：
• Manage staff, including selection, training, development, coaching and termination. Provides an appropriate balance of direction and support to manage the performance of direct reports
• Appraise employee performance and provide feedback and counseling to staff, when necessary.
• Develop succession plans and oversee career development of immediate staff.
• Builds a productive, engaging team culture and climate based on trust, respect, and mutual support
• Clarifies team roles, goals, mission, and ground rules.
• Recognizes and develops the potential of direct reports. Holds professional development and career discussions with direct reports
岗位要求
Educational Background： Academic Degree and Profession AD – Science based BS or MS. Advanced degree (MD, PhD, PharmD) preferred
D – Science based BS or MS. Advanced degree (MD, PhD, PharmD) preferred
SD - Advanced degree (MD, PhD, PharmD) preferred
Regulatory Affairs Certificate (RAC) is a plus but not required for all levels
Professional knowledge：
- horough knowledge and comprehension of regulations, directives and guidelines.
- Knowledge of overall drug development process
- Previous experience in the preparation and submission of regulatory documents
- Previous experience leading a team to prepare for and carry out major health authority interactions
Working Experience：
- Associate Director- Minimum of 3 years of direct regulatory experience in pharmaceutical/biotechnology industry or regulatory agency
- Director - Minimum of 6 years of direct regulatory experience in pharmaceutical/biotechnology industry or regulatory agency; Experience with managing direct reports is a plus but not required
- Senior Director: Minimum of 8 years of direct regulatory experience in pharmaceutical/biotechnology industry or regulatory agency; Experience with managing direct reports is preferred
- Executive Director: Minimum of 9 years of direct regulatory experience in pharmaceutical/biotechnology industry or regulatory agency; Experience with managing direct reports is required
- Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, all with tight timelines
Technical Requirements Knowledge of one global regulatory requirements and advanced knowledge for at least two region ex China (US/EU/Japan)
Other Requirements
- Ability to work in a cross-functional team environment
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
- Creative problem solving/issue resolution skills with the willingness to take risks and act decisively
- Able to facilitate brainstorming in teams and open to creative thoughts of others
- Self-motivated and focused; able to take decisions and be professional and supportive in driving change
- Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters