303 Nda Jobs - Page 12

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...

Legal Advice, Board meetings, committees, Compliances, Administration, Communication, Filing, Training, ROC Compliances, Regulations, Performance Evaluation, Taxation, Drating Minutes, Annual General Meeting etc, GST, TDS etc.

Hiring for a Leading steel Manufacturer Designation : Buyer - MORS Location: Pune Experience: Minimum 3 years for Master degree holder) or 5 years (for Bachelor degree holder) of experience in procurement preferably in industry (metallurgical/mechanical /heavy machinery industry background preferred) Qualification : Master's degree in engineering and/or Business Administration / Bachelor's degree in engineering with relevant experience Work mode: Hybrid Shift Time : 11 AM TO 8.30 PM Responsibilities: Actively participate in the strategic procurement activities for Mill Operations & Recycling Services subcategory in the Cluster Execute supplier selection, negotiation, and contracting for the ...

Hiring for a Leading steel Manufacturer Designation: Buyer - Spare Parts Location: Pune Experience: Minimum 3 years (for Master's degree holder) or 5 years (for Bachelor degree holder) of experience in Qualification: Master's degree in engineering and/or Business Administration / Bachelor's degree in engineering with relevant experience Work mode: Hybrid Shift Time : 11 AM TO 8.30 PM Responsibilities: Actively participate in the strategic procurement activities for their respective procurement subcategory (procurement tenders and project management, long-term contract management, cost reduction actions, supplier panel management etc.). Build transparency of subcategory spend in their respect...

Hiring for a Leading steel Manufacturer Designation: Buyer - Spare Parts Location: Pune Experience: Minimum 3 years (for Master's degree holder) or 5 years (for Bachelor degree holder) of experience in Qualification: Master's degree in engineering and/or Business Administration / Bachelor's degree in engineering with relevant experience Work mode: Hybrid Shift Time : 11 AM TO 8.30 PM Responsibilities: Actively participate in the strategic procurement activities for their respective procurement subcategory (procurement tenders and project management, long-term contract management, cost reduction actions, supplier panel management etc.). Build transparency of subcategory spend in their respect...

Hiring for Legal/Compliance role, somewith with expertise in drafting vendor agreement, NDA, MOUs. Ensure compliance with corporate, legal, and regulatory requirements under applicable laws.Liaise with external legal counsel on company-related matter

Hiring for a Leading steel Manufacturer Designation: Buyer CAPEX Location: Pune Experience: Min 3 to 5 Yrs Qualification: Master degree in a relevant field (e.g. procurement, engineering, mechanics, electrics). Work mode: Hybrid Shift Time : 11 AM TO 8.30 PM Responsibilities: Handling of CAPEX procurement process in coordination with the project manager & under supervision of lead buyer Roll-out the purchasing strategy defined for Capital Goods (project execution strategy, benchmark,etc.) Select appropriate vendors for the tendering process Design the contract aligned with General Conditions for Capital Purchases. Support the design of the contract for projects under Capital Goods responsibi...

About TresVista TresVista is a global enterprise offering a diversified portfolio of services that enables its clients to achieve resource optimization through leveraging an offshore capacity model. TresVista s services include investment diligence, industry research, valuation, fund administration, accounting, and data analytics. TresVista has more than 1,800 employees across offices in North America, Europe and Asia, providing high-caliber support and operating leverage to over 1,000 clients across geographies and asset classes, including asset managers, advisors, corporates, and entrepreneurs. About Department The Legal department at TresVista is responsible for ensuring agreements entere...

Please apply here : https://tatvic.keka.com/careers/jobdetails/79431

EC-Council is the worlds largest cyber security technical certification body. We operate in 145 countries globally and we are the owner and developer of various world-famous cyber security programs. We are proud to have trained and certified over 220,000 information security professionals globally that have influenced the cyber security mindset of countless organizations worldwide. Visit us on www.eccouncil.org. Senior Legal Associate Location: Noida Hybrid Responsibilities: As a Senior Associate - Legal , your responsibilities include but not limited to: Contract drafting, negotiating, vetting and redlining all kinds of agreements and ancillary documentation MSA, RFP, RFQ, SaaS, SHA, Re-sel...

Job Title: Legal Executive Department: Legal & Compliance Location: Pune Experience Required: 12 years Industry: NBFC / EV Financing / Financial Services Job Summary: We are looking for a detail-oriented Legal Executive with 12 years of experience to support our legal operations. As part of an innovative EV financing company, the candidate will be responsible for handling a variety of legal and compliance matters, ensuring that the company operates within the legal framework of financial services and NBFC regulations. Key Responsibilities: Draft, review, and vet loan agreements, NDAs, service contracts, vendor agreements, MoUs, and other legal documents. Coordinate with external legal counse...

Role & responsibilities 1. Business Contracts: Draft, review, negotiate, and execute agreements, including NDAs, MOUs, MSAs, SOWs, Supply & Distribution Agreements, and contracts supporting digital transformation initiatives. 2. Non-Business Contracts: Review agreements for support verticals (HR, IT, Admin, Finance, Secretarial, Compliance) and maintain standard form agreements. 3. Provide contractual support to Redington's APAC affiliates, ensuring alignment with global management guidelines. 4. Identify and mitigate legal risks in business engagements and Ensure execution of back-to-back agreements with channel partners, resellers, and subcontractors to minimize contractual risks. 5. Work ...

Responsibilities:- Draft, negotiate, review, amend the best legal terms in favor of the Company for all NDA's, Service Agreements, Lease Agreement, Addendum, SOW etc.-- including protection of confidential information, intellectual property, Indemnification, loss damages and f jurisdiction etc. Filing of Trademark, reply to examination report, opposition etc. External client management Research on various law and evaluate different risk factors regarding business decisions and operations Ensure proper defense in relation to litigations if any or File timely claims in relation to recovery of Outstanding dues or Assist in appointment of appropriate debt collection agency, issuance of legal not...

Education Post-Graduate, an IRDAI licentiate certificate, Insurance professional qualifications will be an added advantage Experience 6 + years Job Dimensions (role and responsibilities): This will be primarily an individual contributor role reporting to the location leader with no team management role envisaged (except where specifically communicated) The client management team members will however work closely with the client services team allocated (by the location leader) to ensure the quality delivery of client services Responsible for meeting renewal business broking revenues according to annual targets and for completing/handling employee benefit insurance renewals for all existing cl...