Regulatory Affairs Specialist

JOB DESCRIPTION

Jubilant Bhartia Group

Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees.

About Jubilant Ingrevia Limited

Jubilant Ingrevia is now a member of the elite Global Lighthouse Network (GLN) of the World Economic Forum (WEF)

Celebrating our Culture and People.

We are proud to be a Great Place to Work certified!

Jubilant Ingrevia history goes back to 1978 with the incorporation of VAM Organics Limited, which later became Jubilant Organosys and then Jubilant Life Sciences and now demerged to an independent entity as Jubilant Ingrevia Limited, which is listed in both the stock exchanges of India. Over the years, company has developed global capacities and leadership in chosen business segments.

Ingrevia is born out of a union of Ingredients and Life (Vie in French). Jubilant Ingrevia Limited is committed to offering high-quality and innovative life science ingredients to enrich all forms of life.

Jubilant Ingrevia, a global integrated Life Science products and Innovative Solutions provider serving, Pharmaceutical, Nutrition, Agrochemical, Consumer and Industrial customers with our customised products and solutions that are innovative, cost-effective and conforming to excellent quality standards.

Jubilant Ingrevia Limited offers a broad portfolio of high-quality ingredients that find application in a wide range of industries. Jubilant Ingrevia's portfolio also extends to custom development and manufacturing for pharmaceutical and agrochemical customers on an exclusive basis.

Our business is split across 3 business verticals, with global leadership across our key product lines.

Speciality Chemicals: The Specialty Chemical business of Jubilant Ingrevia manufactures Pyridine, Picolines and its forward integration derivatives, which finds application in agrochemicals, pharmaceuticals, dyes, solvents, metal finishes, fine chemicals, semiconductors etc.

We have also launched new platform of Diketene & its value-added derivatives for multiple industry use. We are an established partner of choice in CDMO, with more investment plans in GMP & Non-GMP multi-product facilities for Pharma, Agro and Semi-conductor customers.

Chemical Intermediates: The Chemical Intermediates business has acetic anhydride and value added anhydrides and aldehydes catering to various industries.

Nutrition & Health Solutions: The Nutrition & Heath Solutions business unit offers B3 & Picolinates (Chromium & Zinc) which are fully backward integrated. Our ingredients find application in animal nutrition, human nutrition, personal care, etc. We provide high-quality feed & food additives having application in poultry, dairy, aqua & pet food industry. In Human Nutrition & Health Solutions, we offer food ingredients & premix solutions to nutrition.

Jubilant Ingrevia Limited is supported by five state-of-the-art manufacturing facilities in India. We practice world-class manufacturing processes in our day-to-day operations, assuring our customers with unmatched quality and timely delivery of products through innovations and cutting-edge technology. Transforming Manufacturing for Operational Excellence & Sustainability with zero tolerance to any non-compliance is the core focus of Jubilant Ingrevia Manufacturing.

We have 5 world-class manufacturing facilities i.e. One in UP at Gajraula, Two in Gujarat at Bharuch and Savli, Two in Maharashtra at Nira and Ambernath.

Environment Sustainability

The company is committed to environmental sustainability and supports green chemistry by prioritising the use of bio inputs in manufacturing. Jubilant is one of the world's largest producers of Acetaldehyde from the bio route.

Find out more about us at www.jubilantingrevia.com

The Position:

Organization: - Jubilant Ingrevia Limited

Designation & Level: - Deputy Manager- Regulatory Affairs

Location: - Greater Noida

Reporting Manager: - Vice President & Head- Quality & Regulatory Affairs

Job Summary:

To maintain compliance scheme for both Domestic & International regulations like EU REACH, with other REACH-like regulations of specialty chemicals, as well CIB RC registration, managing life cycle management of chemical and agro products registration, managing SDS and labels on-line. As the Regulatory Compliance Manager, you will be accountable for leading product regulatory activities in the various region through monitoring, developing and implementing strategies/programs to ensure compliance with the required chemical control laws.

Job Responsibilities:

Regulatory Compliance & monitoring for Nutrition and ingredients:

• New product proposal, budget approval, data generation and registrations as per the guidelines of Central Insecticides Board & Registration Committee (CIB&RC) on various parameters
• Preparation of application for various categories of endorsements viz packaging, label extensions, name change etc.
• Ensure on-line updates in SDS, new SDS as per business requirements including translation of SDS.
• Coordination with various Contract Research Organizations (CRO'S) for data generation in chemistry, Packaging and Toxicity. Checking of protocols and study plans for conducting the studies.
• Preparing draft to defend queries raised by the regulatory bodies against any molecule/ product etc.
• Partner with the different functions including R&D, Sales and Supply Chain to communicate regulatory requirements/ information to support business needs
• Ensure compliance with existing domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals as per REACH and respective national laws.
• Interact with regulatory agencies and/or trade associations within defined area(s) of responsibility/expertise, CIB and others as necessary and travel as per business needs to other sites and agency's office to meet
• Monitor regulatory changes, threats and opportunities to evaluate implications towards new and existing registrations
• Ensure compliance with applicable regulations including conducting internal audits at sites to maintain compliance
• Responsible for maintaining proper records, create and manage electronic files of labels and registration certificates.
• Participate and contribute in meetings at Industry forums & committees, Associations and other Government departments
• Get the high-quality dossiers prepared, compiled and submit in accordance with the regulatory requirements to obtain new registration in the International market like US, Brazil, EU, LATAM and Asian countries.
• Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to.
• To work closely with the international consultants to ensure timely registration.
• Good knowledge of International guidelines like OECD, EPA, ANVISA, APVMA etc.
• To find out International GLP Labs for data generation (5 batch, tox, mutagenicity, Physchem etc.) and to generate data on time for timely submission of dossier
• Addressing customer/regulatory queries within timeline with the help of internal CFTs collaborations

Pre-registration / Registration of chemicals and Maintenance

• Responsible for preparation & filing of pre-registration and registration dossiers of chemicals under EU REACH, Korea REACH, UK REACH, Turkey REACH , CIB RC , MCS and Agro registration , manufacturing license and on-line compliance in portal.
• Upgrading / downgrading registered tonnage band as per business requirement and maintenance of the dossiers as per the current requirements

Assessment of New Product Regulatory Requirements

• Provide regulatory guidance/consultancy to the business and R&D teams on compliance strategies for new and existing products

Substance Volume Tracking

• Responsible for maintaining and monitoring the export volume of the products through the ERP system to comply with the registered volume in the respective countries

Hazard Communication

• Review of Safety Data Sheets & Labels and extend support to business on-line.

Customer Queries & Questionnaires

• Provide regulatory inputs on the customer queries & questionnaires.

The Person:

• Educational Qualifications & Experience

• Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science.
• Ph.D in Chemistry with relevant certificates in Regulatory Affairs with minimum of 10-15 years of related experience.

• Technical Skills: (Preferred)

• Microsoft office,

• Other Skills:

• Design Thinking
• Team Leadership
• Communication Skills
• Problem Solving

******************************************************************************************************

Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

To know more about us, please visit our LinkedIn page:

https://www.linkedin.com/company/jubilant-bhartia-group/