Senior RA Operation Specialist (Specialist IV)

Position Title:

RA Specialist III /IV

(Senior RA Operation Specialist)

Typically Reports to:

Position Summary:

Working with RA and co-ordinate with Logistics team (RA OGA) responsibilities includes but not least; released comply with import requirements and to support Port enquiries. Support RA Manager for product registration, Audits , DC Certifications and System Implementation and regulatory compliance Support India Import/Export inquiries at Ports along with OGA activities.

Job Responsibilities

50%

Manage India custom inquires related to licensing activities & OGA e.g. DCGI, BIS, MoeF, DoT, EPR e-Waste, Plastic waste and Battery Waste, CIBRC (Insecticide permission NOC) Animal Quarantine (SIP), Paper Import, Non-ferrous (NFMIMS), paper import (PIMS) and any other related etc.

To assist RA Manager to prepare Regulatory plan, Regulatory reports and Risk management for any new product launch and related documentation.

Apply for new/amend/renew import permits &/or licenses as required. Ensure licenses are maintained, renewed in advance of expiry to prevent delays in imports.

Working knowledge of Veeva, Track Wise, SAP will be Plus. Good Knowledge of Excel required.

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

To maintain trackers up to date and keep the regulatory or project data or records

Ability to navigate and use CDSCO SUGAM portal /Any other Govt Portals like CPCB,L/M, BIS , HSM Div etc.

30%

Liaise with Internal & Global stakeholders for import License /NOC declarations, as required ensuring the import conditions are met.

Provide support , Training, Guidance to internal stakeholders/CHA, import team when requested.

Collaborate & engage with Global stakeholders/partners and collate the necessary information.

Monitor & review any changes to import conditions or requirements. Alert stakeholders of any changes that may impact operation.

Co-ordinate with Logistics and Global logistics /RA for labeling and related activities, In depth Knowledge of Local Labeling and related compliances

To review and support HSN classification codes review and related justification from regulatory aspects.

Support regional import or export documentation and help RA manager for assigned task

Ensure compliance with all laws and regulation governing the importation, supply of biologicals, and other controlled products for India business (includes Customs, Ports, Animal Husbandry /AQ, BIS etc).

Process import licenses and customs clearance queries, liaise with internal stakeholders and relevant authorities to ensure all requirements are met to clear products in a timely manner.

To Coordinate with ADC and Customs and ensuring sample testing /Coordinate with NIB

20%

Experienced on Quality Management System Implementation ISO 9001 2015, ISO 13485

Experienced in Conducting Audits , Internal Audit , Suppliers Audit and warehouse systems/Certifications

Utilize technical knowledge and Judgement to solve problems

CAPA & NC process Management

Strong Oral and written communication and skills

Previous import experience especially importing biological materials &/or medical device, IVDs industry is highly advantageous

Be highly organized with effective time management skills

Excellent team player able to work collaboratively and cross-functionally in a fast-paced environment

Education:

Tertiary education (Science, Pharmacy or equivalent)