Manager-Regulatory Affairs

Organization : -

Designation & Level: -

Location : -

Direct Reports : -

Qualification:

Master’s degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science.

Experience Range:

7-12 years

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.

Accountabilities:

Regulatory Compliance & monitoring

• 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 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.