Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Our Work Matters
AtKindeva we make products that save lives ensuring better health and well-being for patients around the world.
Our Work Matters
As a Regulatory Affairs Specialist at Kindeva your role is essential to ensuring our products remain compliant safe and accessible to patients worldwide. From managing licenses and technical documentation to supporting regulatory strategy and site activities your work helps maintain the integrity of our drug and device portfolio.
Your attention to detail and regulatory expertise directly support patient safety and product quality because atKindeva every submission every renewal and every guideline met makes a difference.
Responsibilities:
- Provide regulatory input to site teams and advise stakeholders on global regulatory requirements for planned and unplanned changes.
- Coordinate and prepare documentation for medical device listings site registrations and CTD submissions.
- Maintain site regulatory files and support activities for annual license renewals DEA/state licenses and new regulatory filings.
- Participate in technical reviews ensuring data aligns with global guidelines and regulatory needs.
- Support post-approval regulatory submissions and lifecycle management.
- Communicate regulatory expectations and timelines within the organization.
- Contribute to continuous improvement by sharing regulatory insights from external feedback and cross-functional projects.
Basic Qualifications:
- Bachelors degree in a scientific discipline
- At least 3 years of pharmaceutical cGMP regulatory experience.
- Practical knowledge of the drug regulatory processes in the US and a background understanding of regulatory processes in other regions.
- General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development manufacturing and marketing and the impact of regulatory changes on business goals/objectives.
- Able to communicate effectively orally and in writing
- Able to work both as part of a cross-functional team but also act independently.
- Knowledge of cGMPs cleanrooms and pharmaceutical processing and plant equipment.
- Self-starter with outstanding work ethic; must be able to perform in a fast-paced multi-product environment.
Physical Requirements:
- Must be able to read comprehend and follow documentation related to GMP and safety procedures.
- May be required to lift or move up to 20 pounds.
- Must follow all GMP and safety procedures in the department.
- Specific vision requirements include close vision distance vision color vision and the ability to adjust and focus.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
