- We are looking for an Assistant Manager Regulatory Affairs
- is a leading international company specialized in offering services related to the chemical s regulations worldwide.
- The majority of our customers are large chemicals manufactures around the world. We offer our customers flexible and secure services in achieving regulatory compliance and making the right business decisions
- To better serve our corporate clients, we are looking for an experienced candidate for the post of Assistant Manager- Regulatory Affairs
Job Responsibilities:
- To ensure that customer products always comply with the regulations of the regions where they want to place it.
- Keep up to date with national and international legislation, guidelines, and customer practices.
- To collect, collate and evaluate data from a range of sources.
- To educate customers on regulatory requirements and keep customer records and product regulatory information up to date and accurate using IT tools
- To prepare and submit quality dossiers/applications online/manually to relevant authorities.
- To develop and write clear arguments and explanations for new product licences and licence renewals.
- Provide necessary technical services for regulatory submissions eg license, notification, registrations and their maintenance etc.
- To handle and resolve queries upon submission in the interest of customers.
- Prepare submissions related to annual updates to dossiers/licence variations/renewals within deadlines.
- Keeping Only Representative/Authorized Representative/etc. related liabilities under no risk category along with line manager.
- To prepare SOP for operation department on regulatory submissions w.r.t. each jurisdiction and guidance.
- Participate in development and execution of new regulatory services
- To review company practices and provide advice on changes to systems.
- Liaise with, and make presentations to, regulatory authorities & clients.
- Participate in training courses of the company
- Other tasks, as defined by your manager.
To be successful in this job, ideally you would have:
- Education background in Chemistry or related subject. Preferably a MS or PhD degree with minimum 5yrs of work experience.
- Knowledge on any of the following Regulations/Software is preferred
- Regulations/Category: BIS Act 2016, BIS Rules 2018 and BIS (Conformity Assessment) Regulations 2018, Drugs and Cosmetics Act, 1940, Cosmetic Rules, 2020, Draft Chemicals (Management & Safety) Rules, Manufacture, Storage, and Import of Hazardous Chemical Rules, 1989 and Chemical Accidents (Emergency Planning. Preparedness and Response) Rules, 1996, E-Waste (Management)
Rules
, 2016, Medical Devices, Agrochemicals/Pesticide, Biocides, Pharmaceuticals, Food Safety and Standards Regulations, 2011, European REACH (Regulation (EC) No 1907/2006) or REACH Like Regulations in UK, Korea, Turkey & UN GHS. - Software: IULCID 6, REACH IT, CHESAR, QSAR, MANAK, SUGAM, AboveTarget CRM, Lisam ExEES, MS Teams, CIBRC, FoSCoS, CDSCO
- Understanding of Regulations, Acts, Rule & framework
- Liasoning with Indian Authorities/Ministries
- Outstanding communication and interpersonal abilities to support international customers.
- Excellent verbal, written, and interpersonal communication skills
- Proficiency with MS office (Word, Excel, Power Point)
- Ability to maintain high standards of accuracy and attention to detail
- Travel to Client sites or Authority offices.
- Must display effective problem-solving skills
- Demonstrates a strong drive for results, ability to work independently and with minimal supervision
