9 Eu Jobs

Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time master’s degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time masters degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Consultant - Regulatory Affairs" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following: Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging markets Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs Providing strategic input to the Management and Partners on regulatory projects Keep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-8 years is mandatory Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc). Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets) CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit. Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills. Accuracy and attention to detail. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-risk scenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time master’s degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

Role: Business Development & Sales Designation: AVP - Regulated Markets Department/Function: International Marketing Section: Regulated Markets(UK & EU) Reporting To: Head International Business. Location : Govandi ( East ), Mumbai ( 2nd & 4th Saturday off, 1st, 3rd, 5th Saturday working ) Job Objective: Initiate, maintain and expand the market reach for USV business in the key territories of US, Canada, UK & Europe Market commercially. Key Responsibility Areas Lead formulations business development function for the responsible geographies. Develop and grow relationships with existing and new partners and identify opportunities to expand business with customers. Achieve Top line and Bottom-line revenue growths. Take lead to maintain sales growth in current and future business. Commercial evaluation of the business case to make it viable to execute new business/ existing business Define targets for the team and drive the tasks to achieve the same. Expand market coverage, identify, strategize, and launch USV in new geographies. Evaluate potential partnerships for strategic fit and revenue growth and expansion of markets. Formulating & implementing new ideas to provide better support or to meet customers requirements. Develop geographies through in-licensing, out-licensing, and alliances and partnerships. Expand product portfolio and identify potential licensing and partnership opportunities globally to expand product portfolio. Lead negotiations and deal structuring for licensing agreements/ Co-marketing. Negotiate agreements, commercial deals with customers. Adhere to sales and expense budget. Lead activities across a cross functional team for launch and lifecycle management of the products. Monitoring business progress of allocated accounts; support lifecycle management of business / products Collaborate with Global Strategy to assess market trends, competitive landscape, and potential opportunities. Network and establish relationships with key stakeholders, including pharmaceutical companies, regulatory bodies, and research organizations. Preparation of NPV, Business cases, sales forecast and other market data analysis Stay updated on industry regulations and market dynamics. Desired educational qualification: Management Graduate + B Pharm + M Pharm Relevant Experience: 20+ years in the pharma industry having BD experience in the US, UK & EU.

Function: Biologics Position: Regulatory Affairs- CMC Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working) Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: 8-12 years Job Responsibilities: 1. Biosimilar Regulated market submissions - US / EU market submission 2. Biosimilar Product Development Strategy for CMC and Clinical 3. Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing) 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 5. MOH Query response 6. Biosimilar Product Life Cycle Management 7. RA support for Plant related QMS activities

Role & responsibilities 1 Responsible for preparation and compilation of new registration and re-registration dossiers for the US/EU countries. 2. Evaluation of queries received from various regulatory authorities and timely response preparation for country submission. 3. Responsible for life cycle management and post-approval activities (variations) for the countries allocated. 4. Coordination with various departments for the arrangement of documents and their review for dossier preparation. 5. Due diligence of documents and registration dossiers before the country submissions. 6 Guiding to F&D/ADL on regulatory intelligence and preparation of developmental documents 7. Responsible for updating and managing regulatory-related software. 8. Artwork review and its management. 9. eCTD software operations Preferred candidate profile Must be good in communication & presentation skills. Good Exposure of RA Europe Market. Perks and benefits

Greetings, As a Professional in our Global Business Tax Team you will build and nurture positive working relationships with teams and clients with the intention to exceed client expectations. The jurisdictions covered will include Thailand, Malaysia, Vietnam, Australia, New Zealand, Philippines, Indonesia, Japan, Hong Kong, China, Singapore, UK, Netherlands, Germany, France Withholding tax Reviewing invoices / transaction data shared, on a daily basis for determination of correct tax to be withheld across entities in the APAC region. Perform withholding tax compliance by extracting the data from ERP, where requested and work with external service providers for performing tax compliance. Manage withholding tax returns reporting compliance using our in-house withholding tax systems. Prepare the withholding tax certificate that is to be issued by the company to its vendors. Perform balance sheet reconciliations of withholding accounts and advice on journal entries for correction of withholding tax including expensing expenses. Work with the client team for correction of withholding tax at the source level, identification of cases where withholding tax is deducted at an incorrect rate or not deducted etc. Handle questions regarding withholding tax from suppliers. Corporate tax Reviewing the financial statements and information provided by the company and preparing the pre-payments income-tax, advance income-tax and computation of taxable income as required per the jurisdictions as identified. Preparing the monthly, quarterly, half yearly and / or annual corporate tax return of the company. Co-ordinating with subject matter expert to secure clearances of the computations so prepared. Assisting the client in submission of the corporate tax return of the jurisdictions as identified. Desired qualifications 2 to 3 yrs of experience in handling withholding and corporate tax compliances. Accounting skills in terms of performing reconciliations. Expertise in excel, google sheets and basic knowledge of ERP systems. Expertise in two or more jurisdiction will be an added advantage. Language skills of the identified jurisdiction would be an added advantage. Location and way of working Location: Ahmedabad, Bangalore, Chennai, Delhi (NCR region), Pune and Mumbai This profile may involve occasional travel to client locations Warm Regards, Deloitte marora.ext@deloitte.com

Greetings from BVR People Consulting!! Position: Regulatory Affairs - Formulation Designation: Executive or Asst. Manager Division: Injectable and Solid oral products Qualification: B. Pharm, M. Pharm and M. Sc (FULL TIME) only Years of Experience: 4 to 8 Years CTC range: 5 to 13 LPA. Job Locations: Bangalore ( Electronic City ) No. of Positions: 04 Job Summary: Compilation and submission of the dossier and query responses as per the EU/UK/ANZ /Israel/Belarus and Ukraine regulatory requirements within stipulated timeframe (for Injectable and Solid oral products ). Interaction with CFTs for product specific requirements and to attend product strategy meetings. Review of final data and technical documents received towards dossier compilation from API team, RnD, IP, PV, QA, Commercial, Packaging and Plant team. Compilation of labelling documents as per current EU/UK/ANZ/Israel/Belarus and Ukraine regulatory requirements. eCTD Publishing of dossiers in DocuBridge software. Product life cycle management for approved Europe products i.e. variation, Renewal and sunset exemption filings. Maintain product database, regulatory files, records and reporting systems. Timely updation and maintenance of RIMS database. Preparation and submission of high-quality national translations for National Phase. Post Approval and Pre approval NOTE: We are looking Notice period 01 month or immediate joiner. Interested Candidates should forward their resume to " ganapathi@bvrpc.com" and also Your Current CTC, Excepted CTC and Notice period. Thanks K Ganapathi Mob. No. 9600387468