Manager/Sr. Manager, Regulatory Affairs (Finance)
Responsibilities:
- Represents the RA function on assigned cross-functional project teams.
- Interprets and applies regulations by creating regulatory strategies.
- Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations.
- Prepares hardcopy and electronic information packages for submission to regulatory agencies.
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
- Reviews validation, clinical and stability protocols and reports for regulatory submission soundness.
- Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations.
- Defines, monitors and receives deliverables for submissions.
- Writes and/or edits submission documents using regulatory templates, or creates new templates.
- Assembles paper and/or electronic copies for submission.
- Monitors new and revised regulatory requirements; disseminates information as directed by management.
- Interacts with regulatory agencies and third party accrediting bodies.
- Prepares internal procedures for continuous process improvement.
- Mentors junior members of the department.
- Provides regulatory guidance and/or training to external departments and partners.
- Assists with resource planning and budgeting as needed.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
- Experience with an in vitro diagnostics device multi-nation company required; pharmaceutical, biologics or medical device companies as alternative.
- Strong understanding of CFDA regulations required; other international requirements - EU, Canada, Australia, Japan and Korea - preferred.
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Strong written and verbal communication skills.
- Team leadership skills preferred.
- Familiarity and ability to work with office automation programs and corporate database tools.
- Strong work ethic and demonstrated ability to deliver assignments on time.
Experience/Education:
- Requires Bachelor's degree or equivalent, may require an advanced degree, in healthcare, diagnostics or related field
- Additional coursework in regulatory or quality strongly desired.
- Managers at this level may become involved in day-to-day activities where their acquired expertise and knowledge provide focus to subordinates.
- Uses interpersonal skills to influence customers, suppliers and other comparable level managers.
- Typically has 7+ years of direct work experience,
