Ra Spec Iii

Overview The Regulatory Affairs Specialist position is responsible for RA QA and co-ordinate with supply chain team responsibilities includes but not least maintaining of documentation and support import requirements ensuring products released comply with import requirements Support RA Manager for product registration and regulatory compliance and to support India Import Export inquiries at Chennai How You ll Make an Impact Ensure compliance with all laws and regulation governing the importation supply of biologicals and other controlled products for the Australian and New Zealand territories includes Customs Biosecurity DAWR AICIS Dept of Health etc Process import permits liaise with internal stakeholders and relevant authorities such as DAFF MPI etc to ensure all requirements are met to clear products in a timely manner Ensure licenses and permits are maintained renewed in advance of expiry to prevent delays in imports Apply for new amend renew import permits or licenses as required Liaise with Internal Global stakeholder for import declarations as required ensuring the import conditions are met Ensure all relevant permits are obtained with the use of agency E g Tradewin or equivalent Collate the necessary Manufacturer s declaration in accordance with import conditions Provide support guidance to internal stakeholders when requested Review and maintain import matrices in accordance with permit commodity and conditions when necessary to ensure are up to date Collaborate engage with Global stakeholders partners and collate the necessary information Support engage with local department operation process improvement Manage India custom inquires related to licensing activities OGA e g DCGI BIS MoeF DoT EPR e-Waste Plastic waste and Battery Waste FSSAI CIBRC Insecticide permission NOC Animal Quarantine SIP Paper Import Non-ferrous NFMIMS paper import PIMS and any other related etc Maintain database library standards reference and guidance documentation to ensure up to date Monitor review any changes to import conditions or requirements Alert stakeholders of any changes that may impact operation To support any Regional RA manager s for Product Registration and Regulatory Compliance Change Management as assigned by RA Manager Ability to represent Act on behalf of RA Organization for any regulatory issues enquiries and any other assigned task by RA Manager Co-ordinate with Logistics and Global SCM for labeling and related activities To assist RA Manager to prepare Regulatory plan Regulatory reports and Risk management for any new product launch and related documentation To review and support HSN classification codes review and related justification from regulatory aspects To maintain trackers up to date and keep the regulatory or project data or records Support regional import or export documentation e g Korea COA SEA change license assessment Support any regional regulatory projects as assigned by RA Manager Previous import experience especially importing biological materials or medical device IVDs industry is highly advantageous Working knowledge of practices and procedures relating to ANZ biosecurity import requirements Be highly organized with effective time management skills Excellent team player able to work collaboratively and cross-functionally in a fast-paced environment What You Bring 8-10 years post grad experience ideally regulatory quality or compliance experience Tertiary education Science or equivalent Strong communication attributes - verbal written and negotiation skills along with tight attention to detail skills and ability to think strategically and work with cross functional teams Who We Are For 70 years Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare As one of the top five life science companies we are a global leader in developing manufacturing and marketing a broad range of high-quality research and clinical diagnostic products We help people everywhere live longer healthier lives Recently voted a Best Place to Work Bio-Rad offers a unique employee experience with collaborative teams that span the globe Here you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see Benefits Bio-Rad s biggest asset is its people and the reason why our Total Rewards deliver programs that provide value quality and inclusivity while satisfying the diverse needs of our evolving workforce Our robust offerings serve to enrich the overall health wealth and wellbeing of our employees through the various stages of an employee s work and life cycle We re proud to offer a variety of options including competitive insurance plans for you and your immediate family Annual Health checkup Marriage Leave Paternity Leave Employee Assistance Programme extensive learning and development opportunities and more EEO Statement Bio-Rad is an Equal Employment Opportunity Affirmative Action employer and we welcome candidates of all backgrounds Veterans people with disabilities and people of all races ethnicities genders ages and orientations are encouraged to apply Agency Non-Solicitation Bio-Rad does not accept agency resumes unless the agency has been authorized by a Bio-Rad Recruiting Representative Please do not submit resumes unless authorized to do so Bio-Rad will not pay for any fees related to unsolicited resumes LI-JK2