Regulatory and Compliance Manager
- Has thorough knowledge of Quality Systems auditing principles and practices.
- Participate in scheduling, and ensure completion of, ISO audits, Internal audits and customer audits.
- Leads all ISO, FDA and customer audits.
- Responsible for ensuring external (supplier/vendor) audits are conducted as appropriate.
- Responsible for working with other employees to resolve compliance issues as appropriate.
- Responsible for ensuring all CAPA found during audits are initiated.
- Trains, supervises, motivates and develops a team of 4-6.
- Manages schedules and workflow of a team of 4-6.
- Liaise with R&D to ensure all new product development is done in accordance with applicable regulations and internal procedures.
- Ensure follow up with personnel on audit CAPA.
- Develop standard tools and procedures to improve audit efficiency.
- Main contact for client requests regarding documentation for registration both domestically and internationally.
- Assist In developing procedures to ensure regulatory compliance.
- Create or maintain technical files as necessary to aid client in obtaining and sustaining product approval.
- Assist in data analysis, preparation of and participation in Management Review.
- Attends and participates in meetings as required.
- Manages site post-market surveillance activities.
- Manages pharmacovigilance activities.
- Manages complaint handling process.
- Responsible for Annual Review of Drug Products.
- Responsible for Design File management/maintenance.
- Responsible for regulatory input into change controls, nonconformances and CAPA.
- Maintains professional growth and development through seminars, workshops and profession affiliations to keep abreast of latest trends In Industry.
- Attention to detail is critical.
- Other duties may be assigned.
- Bachelor's degree in a relevant field (e.g., Law, Business, Science, Engineering) or equivalent.
- Minimum 5 years in regulatory compliance, risk management, or related roles.
- Proven track record of managing compliance programs and interacting with regulatory agencies
- Industry-specific regulations (e.g., FDA, ISO).
- Familiarity with compliance auditing and reporting processes.
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