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Formulation Development(Preclinical) - Exp - 2 To 4 Years || Hyderabad SAI Life Sciences

2.0 - 4.0 years

4 - 9 Lacs

Hyderabad

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Department: Formulations Location: Shameerpet About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Key Responsibilities : 1. Hands on experience in developing and manufacturing oral solid dosage form and enabling/novel formulations for improving the oral bioavailability of new chemical entity (NCE). 2. Hands on experience in physicochemical characterization, solid state characterization, and solid form screening 3. In depth knowledge about physicochemical properties of NCEs that govern developability of drug candidates. 4. Hands on experience in preparation of protocols, guidelines and SOPs for lab equipments/instruments and processes. 5. Should have good understanding about the principles of GLP, GMP and ICH guidelines. 6. Should understand systems and process pertaining to safety, health and environment. Experience/Qualification: M. Pharm with 2-4 years of relevant industry experience. Key Competencies (Technical, Functional & Behavioral): 1. Good communication skills 2. Should possess good team management skills.

Posted 1 week ago

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Executive - Regulatory Affairs Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)

2.0 - 7.0 years

4 - 8 Lacs

Bengaluru

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Roles & Responsibilities Will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department. will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license. will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines will identify and assess regulatory risks associated with product filing. will provide regulatory guidance to company personnel throughout the research and development process. Competencies: Understanding of various regulatory requirements for new drug development Presentation & Communication Skills Interpersonal Skills Proficiency in Kannada Desired Profile : M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies Working experience of IND and NDA filing of NCE and NBE products

Posted 2 weeks ago

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Sr. Executive DMPK Eminence Hr Services Bharuch

5.0 - 10.0 years

6 - 11 Lacs

Vadodara

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Bioanalyst who will be responsible for high-quality discovery bioanalysis to support preclinical in vitro ADME and in vivo PK studies. LC-MS/MS based bioanalytical techniques to analyse biological samples in support of Drug Discovery projects. Required Candidate profile Around 5-8 years of experience in discovery bioanalysis to support in vitro ADME and pharmacokinetic studies.

Posted 3 weeks ago

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Business Development - New Chemical Entity Naukri

10 - 18 years

14 - 24 Lacs

Hyderabad

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Role & responsibilities CDMO Job Description: Manager / Sr. Manager / AGM Formulations Business Development Position Summary: We are looking for an experienced front end Business Development professional to come on-board and contribute to the expansion of Formulation CMO and CDMO business globally by identifying new opportunities and customers in both innovator and generics sectors. Business Development and end-to-end Operations Management: - Identification and generation of new Leads in NCE, 505(b) (2) and Generics segments and product / project evaluation of internal strategic fit - Strong negotiation skills to convert Leads into Business and contribute and meet the assigned Annual Sales Target of Individual and Team - Implementation of Travel plan to aggressively pursue new business meetings on-site and by attending networking conferences - Generation of new business from existing customers - Customer relationship management - Coordination with R&D, PM, SCM, Manufacturing, QA, Finance and all other cross-functional teams - Effective creation and submission of business costings and proposals against RFPs / RFQs - Respond to RFIs on time - Preparation of all promotional material for business development activities. Requirement: - Minimum 10-15 years of experience in front end and capable to travel independently and frequently, to generate revenues from year 1 - Bachelors or Master’s degree in Business Administration, Life Sciences, Pharmacy, or a related field - In-depth knowledge on CMO / CDMO Market research and analysis - Extended hours of work for customer approach by emails and cold-calling in local market time - Excellent communication and negotiation abilities and ability to work under pressure and meet deadlines Work Location: MSN’s Corporate Office, Hyderabad

Posted 1 month ago

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