Manager - Regulatory Affairs

JOB DESCRIPTION

• DETAILS OF THE JOB:
  
  
  

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

• PURPOSE OF THE JOB:
  
  
  

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

• KEY ACCOUNTABILITIES:
  
  
  

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.

• Hazard Communication
  
  
  

Review of Safety Data Sheets & Labels of the hazardous products.

• Customer Queries & Questionnaires
  
  
  

Provide regulatory inputs on the customer queries & questionnaires.

• KEY INTERFACES
  
  
  

External Interfaces

Internal Interfaces

Regulatory Agencies

Business, marketing, R&D and Quality departments

• EDUCATION & EXPERIENCE
  
  
  

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 REQUIRED:
  
  
  

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.