Specialist RA

Coordinate with internal (i.e. Execution team, API-RA, Plant, SCM, CPPK etc.) as well as external counterparts (i.e. external API manufacturing and testing sites etc.) Trigger request for all the administrative documents like foreign CPP, Indian CoPP/FSC/WHO GMP from respective CFT's and list down the open issues, also provide the document request to plant. To co-ordinate and understand the on-going review status of the product in the lead markets and update the API Plus project simultaneously demanding its review stage and tentative approval timeline. Draft deficiency responses, co-ordinate with CFTs, track the action items and review the documents for deficiency response. Display ability for timely response to deficiencies Demonstrate the ability to communicate the essential requirements to CFTs. Provide all the launch sheets and tech-packs, to facilitate timely launch of products. Support commercial team with tender related documents. Archive the submissions, responses, and other data in product folder. Qualification M Pharm/Masters in science Experience : 10 -15+ years Handing the Customer Audits and MoH Audits at our Manufacturing sites. Technical Skills Understanding of Good Manufacturing practice/Quality Systems. Understanding of product development, manufacturing processes, Intellectual Property and quality. Experience in handling various dosage forms like solid orals and sterile dosage forms. Sound knowledge of International Council for Harmonisation (ICH) / European Medicines Agency (EMA) guidelines on submission requirements and basic understanding of global regulatory affairs including United States Food Drug Approval requirements. Behavioral Skills Excellent communication and interpersonal skills. Efficient Leader and a good collaborator. Effective planning and high level of performance orientation. Strong analytical and problem-solving abilities. Additional Information