Title: Director- Regulatory Affairs
Location: Westborough, MA
Schedule: Monday through Friday, 8 am to 5 pm
Start date: Immediate
- Lead AIC’s Regulatory and Quality functions
- Ensure that AIC operates in full compliance with all applicable laws and regulations
- Serve as consultative partner to internal stakeholders to support the proper balance between AIC’s commercial interests and our commitment to full compliance with all applicable regulations.
- Partner with AIC Product Managers to provide regulatory assistance to AIC suppliers
- Establish and/or refine processes to ensure full organizational compliance within a changing regulatory environment that includes US FDA, API Registration and Listing, Health Canada (and regulations governing the importation and storage of APIs in Canada), DMF submissions, FSMA, DOT, EPA, DHS, and others.
- Develop productive relationships with applicable Federal and State regulatory agencies. Serve as AIC’s point of contact.
- Stay current on changing regulatory policies in order to update company management and procedures
- In partnership with HR, develop and implement a comprehensive training program to ensure that employees have the tools they need to ensure AIC’s full compliance with all applicable regulations.
Requirements (Education and Experience):
- Four-year College degree required; ideally in chemistry or the natural sciences.
- At least seven years’ regulatory experience, including solid experience with FDA regulations
- Hands-on experience with paperwork and filings required for full FDA compliance, including those for APIs
- Chemical or pharmaceutical industry experience strongly preferred
- Import and international experience preferred
- Prior experience in the distribution business ideal
Requirements (Knowledge and Skills):
- Knowledge of applicable federal and state regulations
- General knowledge of the import and export, distribution, and/or chemicals industries required
- Familiarity with chemical properties and documentation requirements
- Strong project management skills; demonstrated ability to manage multiple projects simultaneously
- Ability to interface effectively with a variety of diverse stakeholders (including AIC employees, regulatory agencies, and international/domestic partners)
- Strong research skills. Demonstrated ability to absorb and apply new information quickly.
- Proficiency using Microsoft Outlook, Word, Excel, PowerPoint, Adobe Acrobat. Familiarity with Chempax a plus.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.