Regulatory Affairs Manager

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: - Manager- Regulatory Affairs

Location: - Noida/ Greater Noida/ Bharuch

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 DMF filing, life cycle management of active ingredients /supplements category. 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:

• Ensure compliance with existing domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals.
• Proactively monitor, evaluate business impact and communicate new and amended legislation and regulations.
• Act as a SPOC for DMF & Regulatory filing /amendment in various geography, like in US, EU, WHO, Japan, ROW, CDSCO etc.
• Ensure complete life cycle management of DMF /Dossiers for APIs/active ingredients/intermediates, such as DMF filing, access request, address technical queries of agency & customers, change notification, LOAs, and amendment.
• Managing a data base and RA filing plan across the product value chain in various geography
• Coordinate with internal teams on DMF filing requirements and ensure readiness of all data.
• Review of relevant documents and DMF prior to filing and ensure right first-time filing approach
• 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 etc.
• 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 of the hazardous products.

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 10-12 years of related experience.

• Technical Skills: (Preferred)

• Microsoft office,

• Other Skills:

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

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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/