Sr. Executive Regulatory Affairs Exports

ROLE OUTLINE: Responsible to prepare and review documentation to manage new product registration, renewal of existing product license by following all compliance mandate of the exporting country. Manage obtaining necessary certification specific to offshore countrys regulatory affairs mandate and address all relevant queries to support BD team in better client dealing/ negotiation.

KEY DELIVERABLES:

Regulatory Affairs Compliance

• Ensure to handle new product registration as well as renewal of existing product license by preparing and reviewing CMC document, Universal scientific/ technical data specific to the importing country's regulatory affairs mandate.
• Responsible to prepare and manage the Product Registration Dossier by collecting all project specific data like Product Registration Fee, Plant Registration Fee (if required), Product Registration Time, Sample Details, Target Price, Any challenge related to registration/ commercial supply, Any specific legal requirement for Batch to Finished Goods.
• Responsible to cross check, prepare and manage all supporting documentation related to commercial supply like MSDS (Material Safety Data Sheet), Declaration (like FSC, Pork Free Product, TSE BSE Free etc.), NON-DG to effectively execute export commercial logistic requirement by being the bridge between the production plant and client.
• Preparing relevant documentation to register a sample as per the MOH guidelines of the importing country.
• Manage coordination between the costing team and client via BD Team around arriving at product costing by collecting relevant input, preparing data sheet/ documentation.
• Responsible to coordinate on the requirement of specific certification with external agencies like SGS certification to supply in Kenya, Health Certificate for Sri Lankan Market etc.
• Maintaining the product life cycle related data by controlling all technical data from initial stage to product registration stage, commercial supply, renewal registration/ licensing etc to the export market like Myanmar, Combodia, Vietnam etc.
• Coordinating with BD as well as R&D team to ensure meeting export country specific compliance mandate on client requirement around Label Claim (LC), Artwork, Costing, Packing etc.
• Extending required support by managing effective communication channel with the required stakeholder to address any regulatory affairs (export) related concern/ guidance inline to the export countrys guidelines/ compliance mandate.
• Giving technical advice of the highest level to the concerned stakeholders and making an important contribution both commercially and scientifically.
• Being vigilant on RA mandate to avoid any issue caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

CANDIDATE PROFILE:

• Should have sound understanding around Internal Guidelines and Compliance (ICH, WHO-GMP, Regulated & Semi-Regulated Market etc.).
• 5-8 years of experience in Regulatory Affairs Export Market.
• Prefer B.Pharma/ M.Pharma with PDGM International Business.
• Should have strong communication (especially written English) as well as interpersonal skills.
• Should be attentive to detail and a research oriented mindset.

Location: Sector 65, Noida
Work Timings: 9:00 AM - 5:30 PM (Alternate Saturdays Off)