Latest jobs / Legal & Regulatory - Other
https://indigojobs.in/
IndigoJobs29-03-2024<h4>Job Description</h4><div><p>Job Description</p><p>Committed to quality and excellence in compliance and conformance.</p> <p> With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned.</p> <p> Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets</p> <p> Contributes independently and manages own time to meet the timelines.</p> <p> Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.</p> <p> Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.</p> <p> Makes informed decisions on straight cases within guidelines and policies</p> <p> Operate in line with internal SOPs and policies</p> <p> Escalate any potential compliance issues to management</p> <p> Support periodic and ad-hoc system reports to estimate metrics</p> <p> Assist in remediation activities</p> <u> <b>Qualifications</b> </u> <b>Must-Have</b> <ul> <li>Bachelor's Degree</li> <li>Demonstrated experience</li> <li>Proven ability to consistently deliver to time, cost and quality standards</li> <li>Operational knowledge of hardware and software tools required for the job</li> <li>Excellent organizational skills and attention to detail</li> <li>Knowledge of documentation practices</li> <li>Fluent in English, verbal and written </li> </ul> <b>Nice-to-Have</b> <ul> <li>Project Management experience</li> <li>Knowledge across multiple therapeutic areas</li> </ul> <br>Work Location Assignment: Flexible<br> <p> <span> <span> <span> <span> <span> <span> <span> <span> <span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span> </span> </span> </span> </span> </span> </span> </span> </span> </p> Regulatory Affairs </div><h4>Job Classification</h4><b>Industry: </b>Pharmaceutical & Life Sciences</br><b>Functional Area: </b>Pharmaceutical & Life Sciences</br><b>Role Category: </b>Legal & Regulatory - Other </br><b>Role: </b>Legal & Regulatory - Other</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>Pfizer</br><b>Location(s): </b>Chennai</br><b><br /><br /><a href="https://indigojobs.in/job/647961/associate-i-regulatory-conformance-chennai-at-pfizer/">Apply</a><br />
https://indigojobs.in/job/647961/associate-i-regulatory-conformance-chennai-at-pfizer/
[Full Time] Associate I - Regulatory Conformance - Chennai at PfizerThu, 28 Mar 2024 18:24:00 +0530<h4>Job Description</h4><div> <b> <u> Job Responsibilities</u> :</b> <ul> <li> <span> Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. </span> </li> <li> <span> Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for LCM submissions and ensures effective data presentation and quality, by self or under guidance. </span> </li> <li> <span> Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of supplements to ensure effective data presentation and quality. </span> </li> <li> <span> Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (batch records, Exhibit batch and stability protocol). </span> </li> <li> <span> Provides regulatory assessment and supports Change Control Assessment, by self or under guidance. </span> </li> <li> <span> Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate. </span> </li> <li> <span> Provide regulatory support for the assigned products, participates and provides inputs in technical reviews and Change Control reviews as assigned. </span> </li> <li> <span> Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. </span> </li> <li> <span> Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, Team lead and core team. </span> </li> <li> <span> Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects. </span> </li> <li> <span> Responsible for ensuring compliance to Company s submission standards, policies and procedures. </span> </li> </ul> <p> </p> <u> <b> Qualifications</b> </u> <p> </p> <b> Must-Have</b> <ul> <li> Bachelor's Degree</li> <li> 3+ years of demonstrated experience in regulatory affairs or in a regulated industry</li> <li> Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards</li> <li> In-depth knowledge of the current health regulatory framework for drug regulatory procedures</li> <li> Problem solving skills, strong detail, quality and compliance orientation</li> <li> Good verbal and written communication skills and fluent in English</li> <li> Proficient computer skills, e. g. MS Office, MS Outlook, Internet, database use</li> </ul> <p> </p> <b> Nice-to-Have</b> <ul> <li> Master's degree</li> <li> Relevant pharmaceutical experience</li> <li> Strategic thinking with good project management skills</li> </ul> <br> Work Location Assignment: Flexible<br> <p> </p> <p> <span> <span> <span> <span> <span> <span> <span> <span> <span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </p> <p> </p> <p> </p> Regulatory Affairs<p> </p> <p> </p> </div><h4>Job Classification</h4><b>Industry: </b>Pharmaceutical & Life Sciences</br><b>Functional Area: </b>Pharmaceutical & Life Sciences</br><b>Role Category: </b>Legal & Regulatory - Other </br><b>Role: </b>Legal & Regulatory - Other</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>Pfizer</br><b>Location(s): </b>Chennai</br><b><br /><br /><a href="https://indigojobs.in/job/646485/associate-manager-i-reg-cmc-strategy-si-lcm-at-pfizer/">Apply</a><br />
https://indigojobs.in/job/646485/associate-manager-i-reg-cmc-strategy-si-lcm-at-pfizer/
[Full Time] Associate Manager I - Reg Cmc Strategy, Si Lcm at PfizerWed, 27 Mar 2024 10:00:35 +0530<h4>Job Description</h4><div><div><div></div><div><ul><li>Provide legal advice to human resource and other business units concerning a broad range of lab our and employment issues including displacement business transition insourcing and outsourcing of employees Maternity laws PF Gratuity etc</li><li>That candidate needs to work independently and thoroughly research the issue and analyze organize and summarize the data into a well written legal memorandum</li><li>Drafting reviewing of employment related policies procedures employment agreements letters employee communications and settlement agreements to mitigate legal risks</li><li>Understand business nuances and employment policies and procedures on a regular basis and recommend necessary changes as appropriate</li><li>Consistent high quality support to the HR team and all other internal clients</li><li>Advising on structuring employee benefits and incentives in line with the applicable laws and prevailing best practices to ensure good governance</li><li>Support in employee communications and other documents research papers and should be able to discuss and interpret relevant laws regulations and case law</li><li>Handling employee investigations independently and collaborating with HR and ER team</li></ul></div></div><div><div><b><b>Primary Skills</b></b></div><div><ul><li>Should have in depth understanding and knowledge in the area employment and related laws</li><li>Experience in handling internal employee investigations including disciplinary grievance and performance matters</li></ul></div></div><div><div><b><b>Secondary Skills</b></b></div><div><ul><li>Good communication skills</li></ul></div></div></div><h4>Job Classification</h4><b>Industry: </b>IT Services & Consulting</br><b>Functional Area: </b>IT Services & Consulting</br><b>Role Category: </b>Legal & Regulatory - Other </br><b>Role: </b>Private Attorney / Lawyer</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>Capgemini</br><b>Location(s): </b>Mumbai</br><b><br /><br /><a href="https://indigojobs.in/job/639374/hr-employment-lawyer-mumbai-capgemini-at-capgemini/">Apply</a><br />
https://indigojobs.in/job/639374/hr-employment-lawyer-mumbai-capgemini-at-capgemini/
[Full Time] HR (Employment Lawyer) - Mumbai - Capgemini at CapgeminiTue, 19 Mar 2024 07:50:09 +0530<h4>Job Description</h4><p><strong>Datamatics is currently hiring for In-house Company secretary experience in secretarial compliances </strong></p><br><p><strong><u>Roles & responsibility:</u></strong></p><br><ul><li> Convening Annual General Meeting and filing thereof with Stock exchange </li><li> Drafting of various Board Resolutions for Corporate purposes.</li><li> Compliances under SEBI Takeover Regulations.</li><li> Filling of various forms with MCA including XBRL fillings.</li></ul><br><p><strong><u>Requirment:</u></strong></p><br><ul><li>Qualified company secretary (CS), along with LLB preferred not mandatory</li><li>Minimum 5 years of experience into secretarial compliance roles.</li><li> Advantage if working experience from Listed company.</li><li>Can join immediately or within 30 to 45 days only.</li><li>Work from office- Andheri (East)</li></ul><br><br><p>Contact if your profile matches with the requirement</p><br><p>Francis Fernandes- 9619734758 | francis.fernandes@datamatics.com</p><h4>Job Classification</h4><b>Industry: </b>IT Services & Consulting</br><b>Functional Area: </b>IT Services & Consulting</br><b>Role Category: </b>Legal & Regulatory - Other </br><b>Role: </b>Legal & Regulatory - Other</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>Datamatics</br><b>Location(s): </b>Mumbai</br><b><br /><br /><a href="https://indigojobs.in/job/645798/hiring-company-secretary-cs-compliances-at-datamatics-global/">Apply</a><br />
https://indigojobs.in/job/645798/hiring-company-secretary-cs-compliances-at-datamatics-global/
[Full Time] Hiring Company secretary (CS)-compliances at Datamatics GlobalMon, 18 Mar 2024 12:00:00 +0530<h4>Job Description</h4><ul> <li> Provide responses to state and federal administrative agencies, including the EEOC, state and local human rights agencies, the Department of Labor, OFCCP, and other labor and employment-related agencies </li> <li> Works in conjunction with outside counsel and the Associate General Counsel on litigation matters and other pre-litigation disputes, including class actions, employment disputes, contract disputes, litigation, arbitrations, and other dispute resolution proceedings, </li> <li> Work cross-functionally within Legal and throughout the company, developing strong relationships with HR, Finance, IT, Operations, Sales, Marketing, and other business units </li> <li> Manage pre-suit investigations, including document review, witness interviews, and documenting findings </li> <li> Provide advice and counsel to various internal teams to proactively address and resolve potential disputes while providing risk mitigation advice and supporting Company objectives </li> <li> Conduct risk analysis on key matters, draft early case assessments, and issue legal holds </li> <li> Prepare for and participate in depositions, settlement conferences and other court proceedings </li> <li> Tender timely claims to insurers, perform insurance coverage assessments, and respond to requests from insurers </li> <li> Own and manage the document retention policy and legal hold policy </li> <li> Provide timely reporting on litigation and pre-litigation matters </li> <li> Draft and negotiate employment-related agreements, guidelines, contracts, and policies </li> <li> Perform special projects and responsibilities assigned by the General Counsel or Associate General Counsel, Litigation and Employment </li> </ul> <div> <strong> Knowledge, Skills, Other Qualifications: </strong> </div> <ul> <li> Law Degree from recognized university in India; LL.M. from accredited U.S. law school preferred </li> <li> Minimum of four to seven years of litigation-focused experience working in a law firm or in-house legal department; experience with a U.S.-based multinational company preferred </li> <li> Some knowledge of U.S. employment law </li> <li> Experience and interest in civil litigation </li> <li> Excellent communication (writing, speaking and reading) skills in the English language, including a demonstrated </li> <li> Excellent interpersonal skills and ability to serve on and contribute to high-performing teams </li> <li> Strong decision-making, critical thinking, and organizational skills </li> <li> Ability to work independently and multi-task effectively in a fast-paced environment </li> <li> A strong commitment to timely, responsive, and high-quality client service and problem solving ability that successfully addresses business and legal interests </li> <li> Experience and skill working with individuals of different ranks and ability to provide sound and clear legal advice to management and human resources team members </li> <li> Substantial experience with discovery, including e-discovery </li> <li> Ability to handle multiple assignments and manage projects to successful completion </li> <li> A strong work ethic, impeccable integrity, and ethical and professional behavior </li> <li> Ability to adapt to evolving priorities </li> </ul><h4>Job Classification</h4><b>Industry: </b>IT Services & Consulting</br><b>Functional Area: </b>IT Services & Consulting</br><b>Role Category: </b>Legal & Regulatory - Other </br><b>Role: </b>Private Attorney / Lawyer</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>ACS Solutions</br><b>Location(s): </b>Noida, Gurugram</br><b><br /><br /><a href="https://indigojobs.in/job/647232/sr-legal-associate-lead-litigation-noida-at-acs-solutions/">Apply</a><br />
https://indigojobs.in/job/647232/sr-legal-associate-lead-litigation-noida-at-acs-solutions/
[Full Time] Sr. Legal Associate/Lead - Litigation - Noida at ACS SolutionsMon, 18 Mar 2024 12:00:00 +0530