We are looking for an Assistant Manager – Regulatory Affairs
REACHLaw Ltd 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 www.reachlaw.fi
To better serve our corporate clients, we are looking for an experienced candidate for the post of Assistant Manager- Regulatory Affairs
Place of work: New Delhi, Dwarka
Type: Full Time
- 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
As a person, we hope that you can work in an international and fast developing environment and that you are results driven. An ideal employee should have an enthusiasm to work on Indian regulations with an interest to challenge regulators, government departments to handle practical issues being faced by industry players including enforcement to drive changes and advocacy support to assist regulators to meet objectives under legal framework and its implementation.
Send your CV and cover letter by March 31st to: email@example.com
Further questions regarding the vacancy can be sent to: firstname.lastname@example.org