220 Nda Jobs - Page 3

Position/Job Title: Legal Key Requirements: Total 4 years experience Non-Litigation (min. 2 yrs): Drafting and reviewing MSA, SOW, NDA, vendor / supplier contracts Conducting legal risk assessment for tenders / bids Exposure to transactions (M&A, share purchase agreements, due diligence, PE/VC engagements) Litigation (approx. 2 yrs): Experience in society matters, court appearances and coordination Real estate matters (title search reports, due diligence, sale agreements etc.) Qualifications: Graduate

Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical component...

1. Secretarial: i. Conducting/Documenting for Board Meetings/CSR Committee Meetings/Annual General Meetings/Shareholder metings alongwith documentation for circular resolutions in accordance with the Companies Act, 2013 and Rules & regulations thereof. ii. Maintaining & updating all the statutory registers/records etc. iii. Ensuring abidance with event based & annual secretarial compliances. 2. Legal: i. Drafting & vetting of legal-commercial documentation for the Company including commercial agreements, NDA s, MOU s, claim letters ii. Responsible for keeping stakeholders aware and informed of obligations in these arrangements iii. Also enabling the finalization of company s policies/terms &...

Tech Content Writer About the Role We are seeking a detail-oriented Tech Content Writer to create and manage highquality business and technical documents, including software proposals, contracts, agreements, and minutes of meetings (MoMs). The ideal candidate will have strong writing skills with the ability to translate complex technical and business requirements into clear, professional, and legally sound documents that align with client expectations and organizational goals. Key Responsibilities • Draft, review, and edit software proposals, business agreements, contracts, and project documentation. • Convert meeting discussions and technical conversations into structured Minutes of Meeting...

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA. 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages. 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Lab...

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are develop...

We are seeking a qualified and experienced Corporate Legal Counsel with a strong background in corporate law, taxation, and regulatory compliance to join our team, role will work cross-functionally with finance, strategy, investment, external advisor Required Candidate profile The ideal candidate will be responsible for providing legal guidance on business operation corporate transactions, taxation matters, structuring, and general legal risk management in group companies.

Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Ensure timely submission of all assigned projects. Review / prepare documents which meet the requirement set forth by US FDA and accept...

We are seeking a meticulous Legal Operations Intern to handle day-to-day legaloperations including NDA management, contract review, document abstraction, andredlining support for ongoing projects. Key Responsibilities Review, negotiate, and manage Non-Disclosure Agreements (NDAs) Perform contract abstraction and create executive summaries Provide redlining support for various legal documents and agreements Summarize complex legal documents for internal stakeholders Assist in contract lifecycle management Support ongoing projects with legal documentation review Maintain contract databases and tracking systems Coordinate with internal teams on legal requirements for projects Required Qualifica...

Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up ...

Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up ...

Generate leads via LinkedIn, Upwork & emails. Pitch IT services, convert leads, understand client needs, coordinate proposals. update CRM Build long-term client ties, and meet monthly/quarterly sales targets. Flexi working Work from home Sales incentives Performance bonus

Overview STAMPING COMMODITY BUYER Responsibilities Job Summary: The Commodity Buyer will be responsible for the strategy and execution of his/her commodity to meet corporate goals in supply base management, cost reduction, supplier reduction, and quality improvement and part consolidation. One of the primary responsibilities of this position is to develop and implement cost reduction opportunities and building a strategic supply base. Strong emphasis will be on meeting metrics, implementing cost reduction strategies while coordinating business relationships and agreements with major suppliers. The Commodity Buyer will create the supply base strategy and coordinate efforts with the program bu...

Overview COMMODITY BUYER - Injection Moulding Parts Responsibilities Job Summary: The Commodity Buyer will be responsible for the strategy and execution of his/her commodity to meet corporate goals in supply base management, cost reduction, supplier reduction, and quality improvement and part consolidation. One of the primary responsibilities of this position is to develop and implement cost reduction opportunities and building a strategic supply base. Strong emphasis will be on meeting metrics, implementing cost reduction strategies while coordinating business relationships and agreements with major suppliers. The Commodity Buyer will create the supply base strategy and coordinate efforts w...

Position: Assistant Manager / Deputy Manager - Marketing Experience - 6 To 8 Years Contact - 9356395439 Email - punejob2025@gmail.com Preferred Industry - Plastic Injection Molding, From Automobile Industry only. Profile JD: 1. RFQ Generation & Handling. 2. Costing 3. Develop new market & new customers where business is not present. 4. Knowledge of Thermoplastics , Inj Molding, Painting & Plating 5. Prepare and monitor the marketing budget on a quarterly and annual basis 6. Measure and report on the performance of marketing campaigns, gain insight and assess against goals 7. Analyses consumer behavior and adjust email and advertising campaigns accordingly 8. NDA review and updates, Business ...

Working Days - Monday to Saturday Location: Greater Noida (Pari Chowk) Client : Chemical Manufacturing & Energy Transition Must have experience in Corporate Law Side.b Key Responsibilities: 1. Draft, review, and vet various legal documents, including but not limited to: Service Agreements, Vendor Agreements, NDAs, MOUs, Employment Contracts, Lease Deeds, etc. 2. Assist in negotiation and finalization of commercial contracts with vendors, clients, and service providers. 3. Coordinate with internal teams (HR, Sales, Procurement, etc.) to understand business needs and ensure legal compliance in all documentation. 4. Provide day-to-day legal advisory to the management on corporate and operationa...

Designation: Assistant Manager, Company Secretary Location: Gurugram, Haryana Schedule: 45 hours per week Onsite- Hybrid 4 Days work from office Intro : The Assistant Manager supervises the daily operations of the group and ensures that all the communications with clients are supported by emails, outlining agreed action steps, responsibilities, and deadlines. They are also involved in the preparation of budgets and forecasts for the group and comparing these with the previous budgets and forecasts. Our team is dedicated to creating long-term relationships with our clients and business partners, and we strive to provide a personalized and practical approach to our services. We take pride in o...

Job Title: Legal and Contract Manager Company: Hitachi Rail GTS India Noida, India. Salary: As per Industry Company Overview: Hitachi Rail is a leading partner to the world s best transportation companies, with a comprehensive portfolio of rail solutions and services for the urban, mainline and freight railway markets. Job Roles & Responsibilities: Legal and Contract Management support to Hitachi Rail GTS India: 80% Responsible for drafting, negotiating, preparing and managing commercial contracts (e. g. procurement and supplier contracts, service agreements, letters of intent, MOU, NDA, etc ) and company templates (Sales & Purchase T&Cs, ) to be executed from proposal to completion of proje...

3109 Legal Advisor - Intech 3109 Legal Advisor Prepare, amend and evaluate Legal documents like NDA, MSA, AGM MSA and other (Contracts of Associates, Clients and frontend partner) Advise company/MD/CXO s for legal matters Legal Support for long outstanding payments Responding to all legal queries Streamlining legal processes Advising on legal aspects of IPO Protecting the Intellectual Property Rights Monthly meetings with concerned departments Management of relevant records in office Establishing and ensuring a listening and culture of legal department in organisation. Foreseeing the challenges and preparing a legalpreparing legal framework to protect company. On request, participating and l...

Role & responsibilities 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 ANDAs/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 & e...

Summary ~Novartis i m terilerine (CPOlar ve B lgesel pazarlama ve sat ekipleri) e itli d k-orta karma kl ktaki analitik raporlar konusunda analitik destek sa lamak. ~Niteliksel ve niceliksel analitikler sa layarak ve ileterek Novartis i m terileri i in veriye dayal karar vermeyi desteklemek ve kolayla t rmak ~Bilgi payla m , i e al m ve e itim deste i, i le ilgili t m g revlerde/faaliyetlerde destek ekibi lideri, s re dok mantasyonu ve bilgi havuzlar olu turma gibi e itli giri imlere dahil olarak uygulama olu turmada GBS ~ GCO i ini destekleyin. ~ Promosyon pazarlama materyallerinin tasarlanmas ndan sorumlu kapsaml bir tasar m ekibinin ayr lmaz bir par as olmak. About the Role Major Accounta...

Responsible for project planning & implementation for respective PAx. Responsible for identifying & driving cost reduction projects. Support price negotiations, RFQ machines, should- costig & MCR current forecast / target business plan by providing the demand planning by supplier / PAx Responsible for request of quotations (RFQ) for RPP/VCP and preparation f supplier decisions including the necessary documentation in accordance with valid guidelines. Responsible for project related contracts & documents (NDA, N2580. . . . ) Responsible for the necessary information management and key performance indicator tracking for RPP projects for PAx. Gaining the respective technical commodity knowledge...

Responsible for RPP/VCP (BPV or Project leader) project planning & implementation for respective PAx. Responsible for identifying & driving cost reduction projects. Support price negotiations, RFQ machines, should- costig & MCR current forecast / target business plan by providing the demand planning by supplier / PAx Responsible for request of quotations (RFQ) for RPP/VCP and preparation f supplier decisions including the necessary documentation in accordance with valid guidelines. Responsible for project related contracts & documents (NDA, N2580. . . . ) Responsible for the necessary information management and key performance indicator tracking for RPP projects for PAx. Gaining the respecti...

Responsibilities & Key Deliverables Liaison with Platform team and VES COE s for ensuring Program defined TCP are meeting the Targets L1 to L4 Timeplan preparation and monitoring. Ensure control of timeline revisions are updated and communicated to respective COE s Project Risk monitoring and escalation to GPH s/Delivery heads/Vertical Heads/President Gateway deliverables - Activities monitoring and closure, Critical path identification. Represent respective GPH s in NPQ meetings Software releases tracking in line with MPDS Gateway CMTCP monitoring Timeline and Performance Circulate Project MIS report to leadership team Maintain and publish project specific - single issue list and follow-up ...

1. Drafting standard SOWs for clients 2 .Review agreements required by business teams . (i) Preparation of synopsis for client contracts (ii) Preparation of obligation matrix for client contracts (iv) Review of VRF, standard NDA and Agreement, Required Candidate profile 1) Law Graduate with minimum 4-6 years of work experience 2) Strong MS office skills 3) Strong written and verbal communication Share resume on the given mail id shubhi.agrawal@silverskills.com