Regulatory Affairs Specialist

Position Overview

- Co-ordinate regulatory activities in the EEA, Switzerland and non-EU CES countries under the supervision of the Director or Exec. Director of Regulatory Affairs.
- Implement strategies for products in development with supervision and independently develop and execute for registered products.
- Manage submissions and interactions with the EU regulatory agencies.
- Liaise directly with HQ US-based cross-functional teams to communicate regional requirements and ensure compliance with all the required regulations for assigned projects.
- 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 decentralised procedures and provide critical assistance for national submissions in the above-mentioned region.
- Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.

Primary Activities

- Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions in the EEA, Switzerland and non-EU CES countries.
- Under supervision from the Director/Executive Director, Regulatory Affairs Europe, handles new product registrations.
- For assigned development and/or marketed products, contribute to cross-functional Teams and/or lead Teams (for marketed product).
- Works with project teams to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval, under supervision from the Director or Exec. Director. Ensure regulatory strategies are aligned with project teams and business objectives and deliverables.
- Ensures regulatory milestones for assigned projects are met
- Serves as primary regulatory representative to regulatory agencies and 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
- Maintenance of a sound scientific knowledge and expertise for all assigned product areas. Stay abreast on changes in the EU environment which could affect the internal strategy
- In all daily activities, adhere to leadership and compliance standards

Experience:

- Master in pharmacy or chemistry or equivalent preferable in a science related field
- Proven experience in the pharmaceutical industry is preferred
- Experience with maintenance work within regulatory affairs
- Strong interpersonal, oral and written communication skills
- Strong organization and planning skills
- Ability to manage multiple projects with changing priorities
- Knowledge of EU regulations, guidelines and regulatory processes for product life cycle maintenance
- Ability to work in a 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, analyse, and resolve problems in a timely manner
- Fluent English skills (written and spoken)