Senior Regulatory Executive

The
Senior Regulatory Executive
is responsible for internal and external requests from Global Pharma customers and assist to construct the standard excipient tech pack. Designated candidate will respond to customer requests for product and manufacturing site documents and questionnaires for Ingredion products manufactured at our global Ingredion sites, toller manufacturers and products purchased for resale. Must have knowledge of EU/US/PICs/China excipient regulations or other relevant industry knowledge related to develop regulatory documentation support for Pharma grade excipients. The
Senior Regulatory Executive
will meet Global Pharma regulatory team goals and improve the customer documentation system & DMF registration as part of the Global Pharma regulatory system.


Core Responsibilities:

Completing a high volume of complex non-standard document requests including questionnaires, customer specification reviews, and quality & regulatory plant documents, manual reviews.
Being a key point of contact and response for requests from Ingredion Global Key Account customers and to assist the construction of Excipient tech packs for DMF registration as well as Customer regulatory support.
Providing accurate and timely information to our internal and external customers.
Working collaboratively within regulatory team & with technical, manufacturing, quality, and customer support groups to complete customer requests.
Utilizing Sales force software/Global Pharma & Nutra regulatory support team SharePoint to respond to and manage customer requests and need to maintain the active trackers to ensure the requests are complete and prioritized as needed by Salesforce team.
Developing and maintaining a deep understanding of our products and manufacturing sites.
Working as part of a team to ensure the customer documentation response process functions efficiently.
Collaborating with other members of the Global Pharma Regulatory & Quality team and other cross-functional teams to continuously improve the Pharma regulatory documentation process.


Qualified candidates will have:

Mandatory requirements:
Masters degree in pharmacy or demonstrated experience in Global Regulatory/ Quality/ Formulation & Research areas is a plus.
Confirmed ability to work well independently with minimal supervision; actively seeks mentorship when needed to maintain progress on assignments.
Excellent time management skills: ability to handle multiple requests/assignments at a time and complete assigned requests accurately and on a timely basis.
Excellent computer skills: proficient in Microsoft Outlook, Word, Excel, web-based applications.
Excellent verbal and written communication skills.
Excellent listening and communication skills.
Strong attention to detail and excellent organization skills
Basic knowledge of Pharma raw materials/ingredient experience is a plus.

Relocation available: No

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Relocation Available:
No