Specialist - Global Quality & Regulatory Customer Support

JD: Specialist – Global Quality & Regulatory Customer Support

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then we’d like to meet you and bet you’d like to meet us.

Ashland has an exciting opportunity for a Specialist – Global Quality & Regulatory Customer Support team to join our Ashland India business at our Mumbai, MH office. This is a very visible, significant role within the Company and the Quality & Regulatory function. This position will report to Manager - Quality & Regulatory.

The responsibilities of the position include, but are not limited to, the following:

This position is responsible for supporting the product regulatory affairs customer programs supporting LATAM region for excipients, APIs, nutrition products commercial activities and their related operations. The position requires collaboration with regional product regulatory staff, business partners and internal stakeholders from various functional groups. In addition to providing governance and interpretation for regulatory requirements internally.

• 5 - 7 years of Product Regulatory relevant experience.
• Bachelor's or Master's Degree, in chemistry, toxicology, biology or other science discipline.
• Sound technical knowledge of the Pharma regulatory requirements
• Pharmaceutical industry Knowledge & Background
• Background with analytical testing is an added advantage but not a necessity.
• Excellent verbal/written communication skills and ability to effectively present scientific data to management/customers.

Technical Skills, Knowledge and Abilities:

• Computer & Analytical skills (Knowledge of SAP & Salesforce an added advantage)
• Good at Time management & delivering on agreed commitments
• Customer oriented & Problem-solving approach
• Good Listener & convincing Presenter
• Interpersonal savvy & effective Communicator
• Fast learner with a flexible style and the ability to adjust to changing business
• priorities and changing regulatory landscapes
• Responsive and highly accountable: solution-, results- and action-oriented
• Excellent verbal / written communication and interpersonal skills
• Ability to interface with internal and external contacts at all levels
• Excellent organizational and prioritization skills
• Ability to handle multiple tasks / projects simultaneously.
• Actively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safety.
• Improve the organization capacity and capabilities through building collaborative.
• relationships, optimizing diverse talent and utilizing positive communications and influence with others

Responsibilities & Customer Requests:

• Support quality/regulatory queries including quality agreements and any other quality/regulatory requests.
• Collect, evaluate, and collate information from the customer for the standard and non-standard queries and work with internal teams for preparing response to the customer within the set timeframe.
• Proactively work with internal teams to create new statements as per current regulatory guidelines. (i.e. NDMA, TGA compliance, CHP compliance)
• Responsible for preparation and finalization of regulatory standard documents based on the business/ market requirements.
• Drive continuous improvement efforts to satisfy increasing customer expectations.
• Support Ashland’s word class customer experience initiatives in LATAM.

Quality/Regulatory Support for Business Unit:

• Support on quality/regulatory related matters for better understanding regulatory trends and its impact on the business to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Develop or optimize regulatory technical packages to proactively help the Business Development and Sales teams.
• Liaison between the QA/RA team to support the LATAM region
• Participate in applicable regulatory team initiatives, meeting and projects
• Handling Food and pharma excipients and Active pharmaceutical Ingredients
• Preparation, collection, reviewing, and compilation of the technical and non-technical data for applying as per the guidelines.
• Develop standard regulatory procedures, publication of best practice guidelines.