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.
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