Jubilant Ingrevia Limited
Website:
jubilantingrevia.com
Job details:
JOB DESCRIPTION
Designation & Job :
Manager – Regulatory Affairs
Level :
Business Unit :
265
Function :
Regulatory Affairs
Country :
India
Work Location :
Greater Noida
Reporting Manager:
Head – QA & RA
Manager’s Manager:
VP Head – QA & RA
Matrix Manager:
Team Size :
Direct Reportees :
0
In just a few sentences, broadly describe the main purpose of the Job. Indicate what is done and why (outcome). i.e., answer the question, “Why does the Job exist?”
Job Context:
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.
Challenges:
- SCOPE & SIZE OF THE ROLE (Please indicate key metrics defining the size & scope of the role)
Revenue / Operating Budget
As per RA budget plans
Geographical Responsibilities (Global / International / Country / Area with in Country
Will work with the team based out of India
Area of Impact (Dept. Location / Function or Business / Organization)
Regulatory Affairs
Accountabilities Scope Of Work
- Regulatory Compliance & monitoring for Nutrition and ingredients
- Ensure compliance with existing domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals as per REACH regulations across the world.
- 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, CIB Agro registration 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 time line 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.
Review of Safety Data Sheets & Labels of the hazardous products.
- Customer Queries & Questionnaires
Provide regulatory inputs on the customer queries & questionnaires.
External Interfaces
Internal Interfaces
Regulatory Agencies
Business, marketing, R&D and Quality departments
Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this Job..
Education Qualification(Highest )
with Target Institute(s)
Master’s degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science
Desired Certifications :
Ph.D in Chemistry with relevant certificates in Regulatory Affairs with minimum of 8 to 10 years of related experience.
Experience Range :
8 – 12 years
No. of years post Highest Qualification :
8 years
Desirable experience :
10 to 12 Years of Industrial Experience
Skills
Description
Proficiency Level
(General Awareness; Working Knowledge; Functional Expert, Mastery )
Functional Skills
Must be detail-oriented with well-developed organizational and analytical skills
Functional Expert
Behavioral
Skills
Must be self-motivated, capable of managing multiple projects in a fast-paced environment.
- General Awareness : Knows the fundamental or general understanding of concepts.
- Working Knowledge : Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices.
- Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
- Mastery: Candidate is subject matter expert and has command over the subject/ concepts.
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