Assistant Manager - Regulatory Affairs

Topline:

Documentation of Regulatory product Dossiers, Compliance implementation within different verticals with Process and training

Regulatory Auditing skills for the compliance process strengthening

Legislative aspect of Regulations forming and designing

Advocacy -Partnering with Industry association for Industry agenda

Role and Responsibilities:

Knowledge of the regulations as Drugs and Cosmetics Act 1940, FSSAI 2006, Legal Metrology Act 2009, Bureau of Indian Standards (BIS)

Cosmetics Mfg. and Imports documentation as - evaluating, organising, managing, and collating information in a dossier format

Ensuring compliance with regulations set by the FDA/CDSCO/FSSAI regulations for Sales, Storage/distribution purpose

Experience of managing internal documentation repository for the various registration and licensing activities for Cosmetics, Drugs and Accessories etc.

Familiar with Plastic Waste Management Rules 2020, E-Commerce Rules 2020 and Consumer Protection rules 2020 and its applicability to business

Handsome knowledge for the labelling check for Drugs/Cosmetics/ Ayurvedics/ Foods/Nutraceuticals Manage and keeping up to date with changes in regulatory legislation and guidelines applicable to ecommerce business

Experience for dealing with the regulatory offices and presenting organization for the different kind of notice as Legal Metrology violation, Pollution control board, FDA rules violation etc.

International -US, UK, MENA and ASEAN registration experience for cosmetics products.

Requirements:

Experience of 4-7 years (Experience working in Luxury/Cosmetics industry will be preferred) with good verbal and written communication skills. Able to draft the process, reports for management reporting.

Proactive in stakeholders cross functional working for collaboration for regulatory compliance

Skills for identifying the stakeholders /customer needs and upcoming challenges in operation.

External Regulatory authority dealing and negotiation skills as to mitigate the compliance risk.

Able to develop corporate relationship within the external association as for advocating organization agenda.