Specialist RA
- Dr Reddys
- 7 - 12 years
- Hyderabad
- 12 days ago
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Job Description
- 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.
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.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal OperationsRole: Legal Entity ManagementEmployement Type: Full timeContact Details:
Company: Dr ReddysLocation(s): Hyderabad
Keyskills: analytical strong analytical skills interpersonal skills problem solving medicine ipr patent search intellectual property fpa product development science regulatory affairs patents api international technical skills patentability communication skills
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