Regulatory Affairs Specialist
4 weeks ago
Job Summary:
Bausch + Lomb is seeking a highly skilled Regulatory Affairs Specialist to join our global team. As a key member of our CMC strategy team, you will be responsible for developing and implementing regulatory strategies for prescription drugs and consumer products.
Key Responsibilities:
- Develop and implement global CMC regulatory strategies for submissions and content of CMC dossiers.
- Collaborate with R&D and Quality organizations to prepare and maintain CMC sections of submissions.
- Respond to Health Authority queries throughout the product lifecycle.
- Ensure regulatory compliance and change management.
- Provide regulatory support to other company functions during Regulatory Authority inspections.
- Represent Regulatory Affairs on facility/site Local Change Management Boards.
Requirements:
- Bachelor degree preferred or equivalent.
- Minimum of 3 years Regulatory Affairs experience or relevant experience in a regulated environment.
- Excellent communication / interpersonal and writing skills.
- Self-motivated and capable of working independently with minimal supervision.
- Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project).
- Knowledge of country regulations (med device and pharma), post market surveillance, ISO and IEC.
- Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Command of English language (verbal and written).
- Ability to understand scientific information and assess whether technical arguments are articulated clearly.
- Experienced in good documentation practices and requirements for managing regulated records.
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
We Offer:
- Competitive salary & excellent benefits including Medical, Dental, Eye Health, Disability and Life Insurance.
- 401K Plan with company match and ongoing company contribution.
- Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time.
- Employee Stock Purchase Plan with company match.
- Employee Incentive Bonus.
- Tuition Reimbursement (select degrees).
- Ongoing performance feedback and annual compensation review.
About Us:
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world.
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