Ashland Hiring for Product Regulatory Specialist at Ghatkopar, Mumbai, Maharashtra, India Full Time

Job Description

ISP India Private Limited Position Position: Product Regulatory specialist, Life Sciences Asia Reports to: Product Regulatory Affairs Manager, Asia Pacific Location: Mumbai, India General Description Ashland’s Product Regulatory Affairs team applies scientific knowledge and regulatory expertise to develop responsible and sustainable strategies for opening doors to new market opportunities while complying with applicable legislation, mitigating risk to human health, and by advocating to create a competitive advantage for our businesses. We provide practical interpretations for implementation and comprehensive regulatory compliance solutions for our customers to complex problems in today’s evolving regulatory landscape —we are, always solving™. This position is responsible for supporting the product regulatory affairs customer programs supporting Asia Pacific region for excipients, APIs, nutrition and nutraceutical 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. Experience and Education Qualifications

• 5 – 7 years of Product Regulatory relevant experience
• Bachelor or Master Degree, in chemistry, toxicology, biology or other science discipline
• Sound technical knowledge of the Pharma regulatory requirements in Asia region
• 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

Responsibilities Customer Requests

• Support quality/regulatory queries of Asia region 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.
• Create monthly Asia customer reports to identify trends and identify opportunities for improvement
• As requested by the Business Development and Sales organization, develop customized customer request reports
• Drive continuous improvement efforts to satisfy increasing customer expectations
• Support Ashland’s word class customer experience initiatives in Asia.

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 for Asia
• Liaison between the QA/RA team to support the Asia region
• Review sales presentations, or applicable advertising materials to comply with applicable regulatory requirements
• Participate in applicable regulatory team initiatives, meeting and projects
• Support internal quality audits, customer audits activities and other quality related activities identified by the Business development and Sales groups.
• Handling Food and pharma excipients and Active pharmaceutical Ingredients for the Asia-Pacific region (India, South East Asia, Australia, and New Zealand).
• Preparation, collection, reviewing, and compilation of the technical and non-technical data for applying as per the guidelines.
• Applying Import registration certificate to CDSCO through SUGAM Online portal followed by Import license based on the approval status of the subject product.
• Applying Duel Use NOC for India customs clearance.
• Applying Import licenses and other proprietary Ingredients to relevant health Authorities like TGA, HSA, MEDSAFE, FSSAI, Thai FDA etc
• Conduct regulatory reviews on formulations and compliance analysis for destination countries as a part of Ashland’s New Product Introduction (NPI) process for commercializing new products.
• Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to Ashland pharmaceuticals business segments from emerging regulatory issues
• Develop standard regulatory procedures

Regulatory Intelligence monitoring and reporting support

• Ability to keep up-to date with pharmaceutical trends and developments for regulatory/quality for all markets.
• Responsible for quality and regulatory intelligence monitoring for the Asia region
• Create regulatory alerts, notifications to keep the Asia teams up to date with the latest QA/RA trends, opportunities and threats

Industry Associations

• Provide comments for upcoming regulatory/quality requirements as part of the trade associations or Ashland’s initiatives
• Drive regional quality/regulatory advocacy efforts

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.

At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.

Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.

Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit. Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.