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MANAGER, International Regulatory Affairs
Location: New Delhi, India
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 Greater India and S. E. Asia. The individual will provide regulatory compliance expertise for all processes and oversee internal site compliance to applicable regulations, standards, and quality systems through direct interactions across functional lines.
- 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. Interact with global regulatory leaders and peers to expedite approval of pending registrations
- Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
- Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
- Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed. Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
- Develop, track, trend and report to management on compliance metrics. Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action. Coordinate regulatory inspections ensuring oversight from Cepheid’s global Quality group.
- Provide guidance on import/export and distribution activities related to devices and reagents. Manage compliance with trade sanctions regulations.
- Act as a liaison between the company and regulatory authorities, ensuring that products are imported and distributed in compliance with appropriate legislation.
- Participate in the development and execution of quality/regulatory-related training and education.
- Work interactively with cross-functional teams to achieve company business and compliance goals/objectives.
- Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Required Knowledge Skills and Abilities:
- Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
- A minimum of 10-12 years of experience in regulatory/Quality or related departments within an IVD or medical device industry
- 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
- Able to travel ≥ 10-20% per the calendar year
Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.