216 Nda Jobs - Page 8

Job Description 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coa...

Drafting, reviewing, negotiating and end to end management of company contracts with clients, vendors, NDAs etc Interpreting contracts and advising business team on contractual issues Automation of contracts Litigation Management Required Candidate profile Legal professionals with LLB and with a minimum of 2+ years in-house corporate legal departments only. Excellent comprehension, analytical and problem-solving skills

~Provide analytical support to Novartis internal customers (CPOs and Regional marketing and sales teams) on a variety of low-medium complexity analytical reports. ~Support and facilitate data-driven decision making for Novartis internal customers by providing and communicating qualitative and quantitative analytics . ~Support the GBS ~GCO business in application creation by being involved in various initiatives such as knowledge sharing, onboarding and training support, support team lead on all business related tasks/activities, process documentation and creation of knowledge repositories. ~Be an integral part of a comprehensive design team responsible for designing promotional marketing mat...

Role & responsibilities Performs range of legal & finance tasks under oversight of attorneys; specific responsibilities may include (but are not limited to): Allocate work assignments to counsels and keep track of progress in accordance with guidance provided by senior attorneys Draft and/or review NDAs, RFPs and waivers Support attorneys in responses to legal requests, track progress of matters, contract execution process, and filing of executed documents. Support attorneys in enforcing document retention policies and procedures Timely escalating for review by Contracting Coaches (Finance and Legal) and Senior management, against set parameters for the client contracting process Maintain da...

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables f...

Roles Responsibilities : Execute legal agreements (NDAs, MSAs) with internal legal approval. Handle vendor registration with various platforms or customers. Manage internal accounts and documentation. Track regional sales opportunities ensure C4C system updates. Manage empanelment on PSU and government tender portals. Download and review relevant RFPs. Prepare pre-qualification (PQ) and technical qualification (TQ) checklists. Coordinate legal approvals for RFP clauses. Obtain internal approvals Prepare documents with required notarization and stamp paper. Liaise with internal teams to gather documents as per RFP checklist. Communicate with tender authorities regarding deadline extensions or...

1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDA s/NDA s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA s/NDA s. 7. Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & execute the study. 10. ...

Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a team first organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you re looking for.Responsibilities & Skills What Will You Get to Do? Do you enjoy being an integral and valued member of a high-functioning legal team? Would you like to work for an innovative and dynamic multinational corporation? As a Commercial Transactions Counsel at Lattice Semiconductors, you will work on all aspects of commercial contracts at Lattice and work with the Sales, Marketing, Research & Dev...

Designation : Supervisor Posted Date : 21 May 2025 0 Yrs Not Disclosed Noida No.of Openings : 50 Notice Period : 1 Month Job description We have an opening of 50 Supervisor in Spot Billing Pvvnl Cluster project at Noida having 0 years experience . Qualification ITI,B.TECH (ELECTRICAL),B.TECH (COMPUTER SCIENCE),B.TECH (ELECTRONICS) Supervise and manage daily operations and staff. Ensure compliance with company policies and regulations. Monitor and report on performance metrics and KPIs. Collaborate with cross-functional teams on business initiatives. Provide training and support to team members. Maintain accurate records of operations and activities.

Designation : Supervisor Posted Date : 21 May 2025 0 Yrs Not Disclosed Noida No.of Openings : 50 Notice Period : 1 Month Job description We have an opening of 50 Supervisor in Spot Billing Pvvnl Cluster project at Noida having 0 years experience . Qualification B.Com,B.TECH (MECHANICAL),DIPLOMA ELECTRONICS,B.TECH (ELECTRONICS) Supervise and manage daily operations and staff. Ensure compliance with company policies and regulations. Monitor and report on performance metrics and KPIs. Collaborate with cross-functional teams on business initiatives. Provide training and support to team members. Maintain accurate records of operations and activities.

About Scrumconnect Scrumconnect is a leading force in technology consultancy, contributing to over 20% of the UKs most significant citizen-facing public services. Our award-winning team has delivered more than 64 impactful services over the past two years, reaching over 50 million citizens and saving taxpayers over 25 million. At Scrumconnect, we foster a collaborative community of talented consultants who thrive on knowledge sharing, problem-solving, and continuous learning. Our mission is to combine cutting-edge software engineering, human-focused design, and data-driven insights to deliver exceptional service to our clients. Job Summary: Scrumconnect India is seeking a Legal Compliance Of...

Contract management Review NDAs in accordance with internal NDA playbook and manage NDA chart. Coordinate contract and legal department document management. Manage LEI chart and apply for initial LEIs and renewals via Bloomberg. Maintain and update Certificate of Incumbency for funds and corporate entities. Manage and populate contract abstraction chart. Assist with general corporate filings as needed (i.e. prepare FinCen BOIR reports). Manage fund and corporate entities via registered agent portal. Prepare state formation and dissolution entity filings.

MORE ABOUT THIS JOB GLOBAL BANKING & MARKETS Our core value is building strong relationships with our institutional clients, which include corporations, financial service providers, and fund managers. We help them buy and sell financial products on exchanges around the world, raise funding, and manage risk. This is a dynamic, entrepreneurial team with a passion for the markets, with individuals who thrive in fast-paced, changing environments and are energized by a bustling trading floor. RESPONSIBILITIES AND QUALIFICATIONS The Transaction Management (TM) team is a business unit within the Global Banking and Markets division, primarily working with the Asset Financing, Structured Credit & Tra...

Role & responsibilities Core Responsibilities: Design and Analyze PK Studies Plan clinical PK studies synopsis and feasibility Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. Support Drug Development Provide PK and statistical input in clinical development phase studies protocol Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation Support dose selection and optimization strategies for pivotal study design Regulatory Submissions Deep unders...

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the st...

Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific respons...

Exceptional leadership capabilities, with a talent for motivating and engaging teams at every level of nbsp; the organization. nbsp; Proficient in articulating HR concepts and strategies to diverse audiences. nbsp; Proven track record in crafting HR strategies that not only align with but also drive business goals. nbsp; HR Expertise: Comprehensive knowledge of contemporary HR practices, regulations, and ethical standards within nbsp; the industry. nbsp; Talent Management Skills: nbsp; Extensive experience in modern recruitment techniques, talent development methodologies, and nbsp; high-impact performance management systems. nbsp; Strong analytical and critical-thinking skills to diagnose a...

Key Responsibilities: •Litigation Management: •Handle and coordinate civil, commercial, consumer forums, RERA, NCLT/NCLAT, High Court and Supreme Court matters involving the company. •Draft legal pleadings, affidavits, rejoinders, and written submissions in coordination with external counsel. •Represent the company before courts, tribunals, and authorities wherever required. •Contract Drafting & Review: •Draft, review, and vet MOUs, lease deeds, development agreements, buyer agreements, NDAs, work orders, and other commercial contracts. •Provide legal support in documentation relating to project development, homebuyer communications, and compliance undertakings. •Regulatory Compliance & Gove...

Job Title: Business Development Manager Recruitment Services Location: I Floor, Serinity Square Vittal Rao nagar, Mindspace, Madhapur, Hyderabad, Telangana 500081 Department: Sales / Business Development Reporting To: Director / Operations Manager Experience Required: 2-4 years in Business Development (Staffing/Recruitment Industry preferred). Job Summary: We are seeking a dynamic and results-driven Business Development Manager to lead client acquisition efforts and expand our staffing business across IT and Non-IT domains. The ideal candidate will have a strong understanding of recruitment services, excellent communication skills, and a proven ability to bring new clients onboard and build ...

Job Summary Identify key therapy areas / products / complex generics / Sole FTF opportunity for US & OAM markets. Work on various themes to identify low competition ANDA opportunities. Make BC for identified products. Liason with RnD / RA / Clinical / API team / IP / Marketing etc . and compile relevant information. Get Cost of development / capex etc Present shortlisted products to Senior Management for addition to company pipeline, with objectives of achieving the business target and building potential for sustained revenue growth Identify and lead negotiations with CMO / CDMO for novel dosage form products Track Industry news / investor presentations / IMS / new approvals / FTF / Citizen ...

Responsibilities: Spearheading the management of the company's internal contract management tools Drafting of contracts (MSA, NDA, Legal Contracts, Service Agreements) for the client Negotiating commercial contracts with the clients (B2B clients only) Vetting of the contracts shared and proposed by the client for the services to be provided Maintain a roster for renewal of contracts and ensuring that contracts are renewed and active timely and all times Coordinating with finance team to understand impact of the rates and thus partnering with BD team to get better rates for the services Handle the overall contract management for a set of clients based out of the office. Candidate must have: G...

Job Title: Senior Sourcing Engineer - Indirect Sourcing Purpose: The Senior Sourcing Engineer will be responsible for managing and optimizing sourcing activities at GECIA for non-core/indirect procurement such as resource augmentation, software licenses, project services, training, and material procurement. The role emphasizes strong contractual negotiation, vendor management, purchasing compliance, and operational efficiency improvement. Key Responsibilities: Manage end-to-end sourcing operations for indirect categories including external resources, software licensing, project materials, and ad-hoc purchases. Evaluate, develop, and manage the vendor base, including commercial negotiations, ...

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or B...

Were seeking a diligent and proactive legal professional for the role of Senior Legal Executive to support our Legal & Compliance function. Who will handle contracts, compliance, legal advisory, and business communication, working closely with internal stakeholders. Key Responsibilities: Contract & Agreement Management: Draft, review, negotiate, and maintain vendor agreements, NDAs, service-level contracts, and other legal documents. Compliance Oversight: Ensure adherence to applicable laws and regulations across corporate, labor, and sector-specific domains. Monitor changes in regulatory environment and communicate updates to stakeholders. Legal Advisory Support: Provide legal guidance on c...