Regulatory Affairs and Customer Service Coordinator

Description

Vacancy Number: req3390

Location: Thane

Location Address:
1/1 Part TTC Industrial Area, Thane Belapur Road
Koparkhairne, NAVI MUMBAI, 400710
India

Closing Date: 10/31/2023

Be part of our journey
As a global leader in speciality chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate and excited about how we can develop and utilise new technologies to shape and inspire changes within an ever-growing market place.

We have an exciting opportunity for a Regulatory Affairs professional to join our office and handle customers required documents, working in line with local Chemicals Legislations, notification of change for the customers and complaint process.

Our ideal person
As a business, it’s really important to us that we find the best person for the job and that you have the best opportunity to succeed in the role. To help, we have outlined our expectations for the role and what core skills and experiences we require as well as what would make you an ideal fit. In turn, we hope this helps you evaluate if this is the right job for you.

Role and Responsibilities:

Regulatory responsible person who is leading compliance process of relevant country legislations, handling customer requests, management of change for the customers and complaint process.

• Regulatory responsible person for the compliance of the products placed on India market being in line with customs legislations and upcoming regulations
• Leading Ministry registrations (if required)
• Being responsible for local requirements and managing relationships with Ministry or any sector associations
• Following all regulatory updates closely and informing Product Safety Regulatory Affairs (PSRA)
• Supporting all team members for regulatory updates
• Responsible for local Safety Datasheet (SDS) preparation process (if available)
• Providing request of customs (SDS, composition documents)
• Handling customer’ documentation requests (quality, product specific, questionnaires) in coordination with PSRA, related Product Assurance Department (PAD) documents and sites and assisting customers on related regulations (EU Reach, Classification, Labeling & Packaging (CLP) Cosmetic Regulations. etc.)
• Informing customers on change notification for products (management of change)
• Responsible for full complaint process (opening, following up, sharing final reports)

Experience, Knowledge, Skills and Abilities:

Strong understanding of customs and regulatory requirements of pharmaceutical products

3+ years of experience in Regulatory Affairs preferable in OSD or Complex Injectables for India market.

Ability to communicate confidently and effectively both on the telephone and in writing

Good communication skills, excellent planning and co-ordination with a strong attention to detail

Self-motivated and able to work to tight deadlines

Ideally with some experience working in a similar customer facing role

Familiar with MS Office software and competent in SAP/relevant IT business system.

Must know Local and English