Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Senior Regulatory Affairs Specialist managing product compliance within the Medical Division in a hybrid role. Supporting regulatory compliance activities and collaborating with multiple cross-functional teams in an FDA regulated context.
Responsibilities
- Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
- Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
- Evaluate proposed products for regulatory classification and jurisdiction
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
- Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
- Maintain current product registrations and assist with processing registration changes when required
Requirements
- Bachelor’s degree in an Engineering, Science, or equivalent field
- Minimum of 3 years of experience in an FDA or highly regulated industry required
- Minimum of 2 years in a Regulatory Affairs role required
- Preferred RAC certification or Advanced Degree (Masters in Regulatory Affairs)
- Previous experience with US Class II/III medical devices
- Experience authoring regulatory submissions for product approval
- Experience interacting with regulatory agencies
Benefits
- Eligible for bonuses
- Generally eligible for short-term and long-term financial incentives
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