at Terumo BCT
Posted on Oct. 7, 2016
The EMEA Regulatory Affairs Manager will perform all regulatory activities and manage product registrations and submissions for either product lines or geographical areas. As a key member of the Regulatory leadership team, the Regulatory Affairs Manager will play an integral role in helping launch new products and in maintaining regulatory compliance throughout the company.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Understands the importance of regulatory compliance, submissions and communications.
* Ensures that all regulatory activities are conducted with the highest integrity in an ethical manner.
* Acts as primary interface with regulators, presenting strategies and negotiating solutions.
* Experience with most stages of product life cycle.
* Ensures timeliness of regulatory submissions, including vigilance reports, according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.
* Will concentrate on new product development and post-market applications of existing products.
* Initiates own projects at the product level.
* Provides direction to subordinates.
* Routinely works independently on complex issues.
* Actively participates and provides input to cross functional teams.
* Ensures that projects are completed on schedule.
* Reviews completeness of submissions, checking for consistency of the "story".
* Responsible for projects and complicated, novel regulatory submissions.
* Understands how product approval strategies interact with business strategies.
* Develops and mentors subordinates on regulatory principles and key corporate values.
* Participates and promotes subordinate participation on cross-functional teams.
* Prioritizes and manages resources effectively to optimize the value for the overall business.
* Prepares/oversees the development of submission packages for national and international regulatory submissions.
* Familiar with requirements required to work with cross-functional teams on high-priority events.
* Identifies regulatory and clinical challenges and communicates these to senior management.
* Ability to collaborate with scientists and engineers and to be firm when requesting and discussing required data.
* Creates an ongoing, proactive relationship with internal scientific and marketing colleagues.
* Communicates regulatory strategy effectively to all departments to achieve timelines.
* Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims.
* Acts as an effective regulatory consultant to management and other functions, striving to achieve the goal of "one voice" from the Regulatory department.
MINIMUM QUALIFICATION REQUIREMENTS
* Minimum of Bachelor's degree (scientific degree preferred) or equivalent. An advanced degree is preferred.
* Minimum of 10 years regulatory experience with increasing responsibility in the medical device or pharmaceutical industry, and 1 year previous management experience (or equivalent).
* Experience in working with a regulatory authorities (e.g. FDA, ANSM, MHRA, etc.)
* Experience in working remotely with cross-functional and cross-cultural teams.
* A demonstrated track record of creating regulatory submissions from internal reports.
* Experience in gaining FDA or Notified Body approvals for devices.
* Knowledge of Blood Directive and regulations in additional geographies is a plus.
* In line with Terumo BCT Core & Leadership Competencies
(Conflict Management, Developing Direct Reports and Others, Managerial Courage, Business Acumen, Timely Decision Making, Building Effective Teams, Managing Vision/Purpose, Peer relationships, Priority Setting, Drive for Results, Customer Focus, Perspective, Dealing with Ambiguity, Process Management, Cross- Cultural Resourcefulness)
* Strong emphasis on technical aspects of regulatory profession, combined with scientific understanding and strong project management
* Understanding of how product introductions and regulatory success impacts business goals.
* Able to make ethical decisions and communicate choice between two good options.
* Ability to select best options from those with competing factors.
* Has established credibility and is not captured by group-think.
* Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
* Ability to communicate confidently and effectively with regulators and regulatory agencies.
* Demonstrated creativity and the ability to think "outside the box".
* Proven judgment in difficult situations. (Basically the ability to sort through layers of grey.)
* Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
* Willingness to take ownership and accept responsibility for actions and decisions.
* Must be detail oriented, well organized and able to work both independently and in teams.
* Excellent interpersonal, verbal and written skills.
* Demonstrated ability to lead people, including direct reports, and get results through others.
* Ability to communicate effectively in both informal and formal settings.
CERTIFICATES, LICENSES, REGISTRATIONS
Regulatory Affairs Certification (RAC) is a plus.
Expertise in Microsoft Office applications is required.
* Based: Brussels Office EMEA
* Reporting to: Senior Regulatory Affairs Manager
* There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions.
* Some travel may be required (15%)
EXPERTISE: Regulatory Affairs
EDUCATION: Master's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
EXPERIENCE: Minimum 5 years experience