Global Regulatory Affairs Specialist
The role of a Global Regulatory Affairs Specialist is to provide regulatory support for the submission of products in various global markets.
1. Support the preparation and submission of CMC-related information and regional information for all submissions where CMC support is required.
2. Monitor and manage the submission work in conjunction with relevant country Affiliate representatives and other stakeholders such as CMC Reg Associates, Regional Submission Associates, Regulatory Scientists, and manufacturing sites.
3. Provide business process knowledge and regulatory subject matter expertise as appropriate to all stakeholders.
Functional Expertise:
* Contribute to the global submission strategy by developing and utilizing appropriate Information management expertise and country specific knowledge to support the regulatory documentation required for all CMC elements of CTD module 1 and any regional information.
* Coordinate global registration activities and request/provide the necessary documentation to affiliates for registration of products in global countries.
Responsibilities:
* Prepare updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements primarily for module 1 support.
* Communicate and adhere to document naming convention and classifications requirements, revision management, and documenting 'reasons for revision' to facilitate accurate record keeping.
* Oversee and manage activities to register new products and renew existing products in global markets.
Qualifications:
* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
* Knowledge of pharmaceutical drug development or industry-related experience preferred.
Benefits:
* Drug development process or Industry-related experience.
* Knowledge of Agency submission procedures and practices.
* Knowledge / awareness of emerging submission electronic standards.
Others:
* Ability to operate and manage operational requirements in a regulated environment.
* Written, spoken and presentation skills.
* Effective interpersonal skills.