MANAGER, International Regulatory Affairs
The Manager, International Regulatory Affairs will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on Africa, S.E. Europe, Middle East and surrounding countries. Assist with ROW submissions as required.
Responsible for regulatory project timelines and management of global regulatory submissions.
Lead regulatory activities including planning and reviewing of regulatory submissions.
Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.
Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
Interact with global regulatory leaders and peers to expedite approval of pending registrations
Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
Support RA functional area in the review and approval of Change Orders.
Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.
Maintain a "focused urgency" as required by specific events
Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
Assess potential impact and/or applicability to other related areas
Assess corrective action to assure it prevents recurrence
Provide regulatory training to cross-functional groups
Required Knowledge Skills and Abilities:
Bachelor's degree in a Life Science or related field preferred with 9 years experience. Or, equivalent combination of education and experience to perform at this level
A minimum of 5-6 years of experience in regulatory/Quality or related departments within an IVD or medical device industry
A minimum of 3-5 years management experience with atleast 2-3 direct reports
Must be detail oriented with well-developed organizational and analytical skills
Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment
Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Strong oral and written communication and presentation skills
Effective communicator of technical & non-technical information
Ability to work in a self-directed manner to see issues through to completion
IVD product experience is highly preferred