Senior Regulatory Affairs Associate
9-month initial contract
$47/HR with benefits provided
Orion Group is seeking a Senior Regulatory Affairs Associate to work fully remote for our medical device manufacturing client located in CA.
The Senior Regulatory Affairs Associate will provide regulatory support and expertise associated with drug product registrations for I.V. Solutions portfolio, including in-depth analysis of the requirements and tracking of deliverables. They will also execute submission strategies to maintain drug product registrations in line with regulatory requirements and guidelines, and assures full regulatory compliance of all documentation for submissions.
Senior Regulatory Affairs Associate Responsibilities:
- Provides regulatory support for maintenance of commercial drug products with minimal oversight.
- Independently prepares drug product submissions in alignment with regulatory strategy.
- Assesses scientific data provided for submission purposes to ensure it meets regulatory requirements.
- Identifies gaps in drug product submission and executes plans to mitigate risks with management oversight.
- Responsible for tracking and completion of assigned drug product registration activities and commitments. Accountable for accuracy of work and meeting deadlines.
- Makes independent judgments and decisions based on regulations and professional experience, with management oversight as appropriate.
- Supports special projects and process improvement initiatives as assigned.
Senior Regulatory Affairs Associate Qualifications:
- A degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field that will assist with technical writing and in problem solving technical issues as they relate to global drug product registrations.
- Minimum of seven years of pharmaceutical industry/products experience with a minimum of five years in Regulatory Affairs
- Direct experience authoring drug/pharmaceutical product submissions, supporting US and Canada
- Experience successfully preparing drug product application supplements and obtaining associated approvals.
- Experience successfully preparing and maintaining Type III Drug Master Files amendments and (A)NDA supplements is preferred.
- Advanced experience with authoring global drug product registrations.
- Should have previous experience independently authoring submission content, inclusive of Annual Report and PADER submissions.
- Strong project management skills and ability to manage multiple drug product submissions simultaneously.
- Sound knowledge of applicable portions of agency regulations and guidance documents
- Able to follow scientific arguments.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.