Вакансии

Responsibilities:

• Well-versed knowledge of Patent Law provisions and recent case-laws of US/EU.
• Basic understanding of Regulatory Law (like DE/ME, ODE, PIP extensions) in US/EU & RoW countries.
• To conduct prior art & patent searches, prepare landscape reports, Infringement Analysis Reports for EU Markets and RoW market
• Conducting IP Due Diligence activity (Landscape reports, review of the dossier, monitoring of relevant patent/applications) for In License projects for US /Europe & RoW.
• To prepare the Patent Invalidation report for filing TPO, Pre-grant, Post-grant opposition as and when required.
• Able to highlight relevant IP & provide clearance to the formulation strategy, trade-dress/packaging strategies.
• Able to provide IP support to R&D, BD & Portfolio.
• To keep monitoring IP scenarios, competitive intelligence and to timely update about the changed scenario in order to take action timely.
• To have knowledge of trademarks/copyrights.

 

Qualifications:

M. Pharm/ Industrial Pharmacy/ Pharmaceuticals Sciences

Experience:

06-08 years of exp in handling IP activities for Formulations.

Role & Responsibility:

• Meeting the customers expectation by Listening and tailor making services to meet their objectives
• Exceeding expectations of Internal (GM’s) and External (Factory Logistics) Stakeholders by being pro-active decision-makers to mitigate supply chain risk.
• Familiarize and must be updated on the Customs and Import processing of South East Asia countries
• Co-ordination and documentation with Stakeholders to delivering the goods within shortest time to the airport/port. Documentation with 75% accuracy, with no delay or errors. Revisions must be treated 3 hours upon request. Final documents to be sent with 100% accuracy
• Smooth clearance of shipments at destinations and delivered to customers in record time.
• Delivering orders within the shortest time from port/airport after clearance to customers warehouse within same business day. Documentation with 95% of internal accuracy, with no delay or errors. Documents to be sent to customer with 100% accuracy.
• To constantly check and ensure that details keyed in the sales force are accurate.
• To understand and learn the process of salesforce; able to generate sales reports for reconciliations.
• Budgeting and working on an efficient strategy to maximize output, minimize cost wherever possible, add substantial value to the overall team.

Experience Required:

• Minimum 05 yrs

Responsibilities

• Experience in reporting, MIS, consolidation financial statements, Budget and Analysis activities from the manufacturing industry.
• Preparation and finalisation of accounts i.e. Balance Sheet along with derivation of key accounting and business ratios, cashflow, capital expenditure spent, along with reasons for major shift in ratios as per schedule III of Co Act 2013
• Responsible for checking and verification of accounts in compliance with accounting standards.
• Preparation and presentation of accounts for management purpose on monthly basis which is followed by contribution analysis, variable and fixed expenses checking and analysis.
• Confirming vendor and debtor balances , making provisions, inventory report checking , and other variance analysis.
• Planning of fund requirement on monthly basis with liaison with top management and coordination with operational managers for smooth operations of the company.
• Preparation of fund utilization summary on weekly basis to have track on fund requirement and to have check on additional funding requirement, if any
• Prepare SOPs and controls for harmonization / optimization of various activities of Finance function at site & business level.
• Handling of various bank accounts held by the company  to check bank balances on a daily basis in order to take decisions on movement of funds for operational purpose and release of payments as per funding plan.
• To monitor physical cash of head office on weekly basis and to monitor cash expenses taking place at various locations on weekly basis to have control on the same.
• To monitor sales and sales realizations on weekly and monthly basis by comparing the same with targets set by management and escalation to sales department and top management in case of short sales realizations.
• Assisting in Automation process and new tool implementation for Management reporting – MIS, Budgeting & planning, Forecasting.
• Involved in supervision of indirect taxation activities like vat, Service, TDS, GST Assessments etc.
• Preparation and checking of costing / cost sheet of company.
• Involved in making budgets and budget consolidation and analysis of budget vs actual.
• Coordination with auditors and resolving queries raised by auditors.
• Coordination with internal auditors in order to assist them in planning effective internal audits.

 

Requirements

• 3-5 years of experience.
• Qualified Chartered Accountant (preferred)/ Inter CA
• GST related experience mandatory
• Good hold on taxation

Responsibilities:

• Conduct database searches and systematic reviews including citation/full article assessment and data extraction.
• Performing the first pass and second pass,Full text search and data extraction.
• Performing the conference searches and bibliography of SLRs.
• Assisting the senior team members in making the reports and performing the secondary research.
• Quality check data and reports versus source documents.
• Design of protocol, and search strategies.
• Broad experience and knowledge of conducting meta-analysis, indirect analysis, and mixed treatment comparison (MTC) using software such as Stata, R, Excel, WinBugs.
• Involved in the preparation of power-point presentations, data workbooks, posters, manuscripts, HTA/NICE compliant systematic review reports etc

 

Requirements:

• Pharma (Pharmaceutical/Pharmacology)
• 3-6 years of experience

Role & Responsibility:

*The role of Regulatory Affairs Officer focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives;

*Maintaining regulatory compliance of products for the following regulatory activities: initial, renewal, variations, promo permits, marketing materials, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity.

*As part of a global team, active participation in cross-functional teams (Supply Chain, Marketing, Medical Affairs & QA) within the company is a critical part of this role. The provision of regulatory expertise and insight as well as updates on current local regulations and potential changes that will impact the business environment is a fundamental part of the role and as such good communication skills and proactiveness are highly prized.

Key Skills & Knowledge Required:

• Familiarity and experience with Drugs , food products, Food supplement, Herbal , Traditional medicines , Per-biotics , Pro-biotics, devices and other hospital/healthcare practices.
• Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications and Power Point.
• Substantial experience in and understanding of role of RA and regulatory requirements in Life Sciences Industry including ICH requirements and regional requirements and understand current trends in the local market.
• Good project management skills with the ability to prioritize and multi-task.
• Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.
• Flexible «can do» attitude needed to thrive in an ambitious and fast-growing company.
• Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
• Good communication skills, especially as it relates to transparency, collaboration and ability to work across communication channels.
• Self-motivated, able to work independently, enjoys a good challenge and remains focused even in the face of setbacks.

Qualification:

BA/BS/University degree required, Life Sciences/ Health Sciences preferred.

Masters in Regulatory Affairs

Experience Required:

• Minimum 5 year experience in performing regulatory affairs responsibilities from the Pharma (Drugs) and/or Medical Device/ Food Industry / food supplements of which at least 2 years are performed in a supervisory/specialist level.

• Experience in preparing a product dossier as per ICH guidelines.

• Experience of working on a e-dossier management system.