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6.0 - 11.0 years
7 - 17 Lacs
Mumbai
Work from Office
We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .
Posted 1 week ago
8.0 - 10.0 years
8 - 13 Lacs
Ahmedabad
Work from Office
Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of dossier preparation guidelines for USFDA submissions. Excellent communication skills for effective collaboration with internal stakeholders.
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
delhi
On-site
The Regulatory Compliance Manager position is a full-time role based in Delhi, India. As the Regulatory Compliance Manager, you will be responsible for ensuring the company's compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations. Your daily tasks will involve obtaining permissions from Custom authorities, implementing compliance mechanisms for MOOWR and AEO, and liaising with Custom and SEZ authorities to secure timely permissions for Laureate's clients. To excel in this role, you should possess a strong understanding of regulatory compliance and requirements, particularly in Custom and SEZ compliances. You will need to obtain various permissions from DGFT authorities for Advance Authorization and SEIS. Your analytical skills will be crucial in navigating Custom regulations and permissions effectively. A background in Regulatory Affairs and compliance is preferred, along with excellent organizational and communication abilities. The ideal candidate will be able to work both independently and collaboratively, demonstrating a high level of familiarity with regulatory standards in the environmental sector. A Bachelor's degree is required for this position. Salary will be offered as per industry standards.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
saharanpur, uttar pradesh
On-site
Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is structured into two primary segments: Specialty Pharmaceuticals and Generics & APIs. Under Specialty Pharmaceuticals, the company specializes in Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. The Generics & APIs segment focuses on Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) serves as a wholly-owned subsidiary of Jubilant Pharma with Research & Development units located in Noida and Mysore, India. JGL operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, producing APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, approved by USFDA, manufactures APIs targeting Lifestyle driven Therapeutic Areas such as CVS and CNS. It is a market leader in four APIs and among the top three players for three others. The Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, focusing on a B2B model for EU, Canada, and emerging markets. Both manufacturing units are supported by a team of 500 research and development professionals based in Noida and Mysore. The R&D team is dedicated to developing new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. The in-house 80 Bed facility conducts all BA/BE studies and holds certifications from various global regulatory authorities. JGL's Regulatory Affairs & IPR professionals manage a unique portfolio of patents and product filings in both regulatory and non-regulatory markets. The company has shown consistent revenue growth, with INR 53,240 Million generated in the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. For more information about the organization, please visit www.jubilantpharma.com.,
Posted 1 week ago
5.0 - 10.0 years
0 Lacs
haryana
On-site
The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
kochi, kerala
On-site
You will be responsible for extending the global reach of the company through expert discovery and exploration of new and untapped business opportunities and relationships. As an International Business Developer, your primary role will involve finding and retaining clients, encouraging existing clients to purchase additional products or features, and staying informed about changes in consumption trends. Your key responsibilities will include performing business development activities in the pharma or Medical Device domain, demonstrating the ability to source leads from the international marketplace, generating leads, converting them into projects, and possessing experience in international business development. Fluency in German or French is preferred for this role. To qualify for this position, you should have a degree in BVSC, BHM, BHMS, B.Pharma, BAMS, or any other specialization at the graduate level. Additionally, a postgraduate degree such as MS/M.Sc in Biotechnology, Agriculture, Bio-Chemistry, Biology, Botany, Chemical Engineering & Materials Science, Chemistry, M.Pharma, or M.Tech in Environmental, Instrumentation, Bio-Chemistry, Bio-Technology, Biomedical, or Chemical is preferred. The ideal candidate should be familiar with the Pharma international market, Research & Development, and Regulatory Processes. Prior experience in Regulatory affairs or licensing Pharmaceutical products or medical devices is a plus. Strong negotiation skills are essential for this role.,
Posted 1 week ago
1.0 - 5.0 years
0 Lacs
navi mumbai, maharashtra
On-site
The Regulatory Affairs Associate is a project manager responsible for the RA lifecycle management on Medis dossiers for Teva's 3rd party client business (Medis), ensuring that information flow and provision of supportive documents reach the clients. The PM is responsible for liaising with Teva's 3rd party client business (Medis) supply chain, Teva site RA, and other relevant functions. In this role, you will be responsible for lifecycle management on specific products for Europe and the international market. You will ensure that regulatory modules under your responsibility are up to date and in accordance with agreed procedures. You will inform, prepare, and submit variations either directly to authorities or to Teva's 3rd party client business (Medis). Additionally, you will follow up on variation submissions, timelines, and approvals, compile answers to any deficiency questions from authorities or clients, and ensure timely communication of outcomes of variations. As a Regulatory Affairs Associate, you will provide regular status updates to management, set goals, and follow up with your supervisor. You will engage in professional communications with both internal and external stakeholders and work on other specialized projects as defined by RA managers. To qualify for this role, you should have an M Pharm/ MSc with 2 to 3 years of experience in RA or a B Pharm/BSc with 3 to 5 years of experience in RA. A minimum of one year of relevant experience in the EU is required. Personal characteristics that are essential for this role include good organizational, communication, and presentation skills, as well as proficiency in written and verbal English. Strategic thinking, flexibility to adapt to changes, teamwork, good computer skills, and a proactive approach to work are also important qualities. This position reports to the Manager of Regulatory Affairs. Teva is committed to providing equal employment opportunities.,
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
saharanpur, uttar pradesh
On-site
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. Our business is organized into two segments - Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread over 69 acres, is a USFDA approved facility producing APIs for global sales, with a focus on Lifestyle driven Therapeutic Areas like CVS and CNS. The Roorkee facility is state of the art, approved by multiple regulatory bodies, and operates on a B2B model for EU, Canada, and emerging markets. Backward-integrated manufacturing units are supported by around 500 research and development professionals based at Noida and Mysore. R&D activities include the development of new products in API and various dosage forms like Oral Solid, Sterile Injectable, Semi-Solids, Creams, and Liquids. In-house BA/BE studies are conducted at our 80-bed facility with global regulatory accreditations. JGL's Regulatory Affairs & IPR team ensures a unique portfolio of patents and product filings in regulatory and non-regulatory markets. The revenue of Jubilant Pharma has been on the rise, reaching INR 53,240 Million in the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. For more information about our organization, please visit www.jubilantpharma.com.,
Posted 1 week ago
4.0 - 9.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports Required Candidate profile Good relevant experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU
Posted 1 week ago
2.0 - 4.0 years
5 - 8 Lacs
Bengaluru
Work from Office
We are looking for a highly skilled and experienced Risk Management Specialist to join our team at Uniqus Consultech, an IT Services & Consulting company. Roles and Responsibility Develop and implement comprehensive risk management strategies to mitigate potential risks. Conduct thorough risk assessments and analyze data to identify trends and patterns. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Design and maintain effective risk management frameworks and procedures. Provide expert guidance on risk management best practices to stakeholders. Monitor and report on risk management performance metrics. Job Requirements Strong understanding of risk management principles and methodologies. Excellent analytical and problem-solving skills with attention to detail. Effective communication and interpersonal skills to work with diverse stakeholders. Ability to prioritize tasks and manage multiple projects simultaneously. Strong knowledge of industry standards and regulations related to risk management. Experience working with risk management tools and technologies.
Posted 1 week ago
2.0 - 7.0 years
3 - 7 Lacs
Gurugram
Work from Office
Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.
Posted 1 week ago
2.0 - 5.0 years
15 - 19 Lacs
Bengaluru
Work from Office
We are looking for a skilled professional to join our team as an Operations & Strategy Role in Hevo Data, located in [location to be specified]. The ideal candidate will have 2-5 years of experience and a strong background in operations and strategy. Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Analyze data to identify trends and areas for improvement. Collaborate with cross-functional teams to drive process improvements. Design and implement new processes and procedures to enhance efficiency. Monitor and report on key performance indicators to stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Strong understanding of operations and strategy principles. Excellent analytical and problem-solving skills. Ability to work collaboratively with cross-functional teams. Strong communication and interpersonal skills. Experience with data analysis and interpretation. Ability to adapt to changing priorities and deadlines.
Posted 1 week ago
2.0 - 7.0 years
5 - 9 Lacs
Noida
Work from Office
We are looking for a highly skilled Legal-Drafting Expert with 2 to 7 years of experience to join our team at HouseEazy. The ideal candidate will have a strong background in drafting legal documents and providing expert advice on legal matters. Roles and Responsibility Draft, review, and negotiate legal documents such as contracts, agreements, and policies. Provide expert advice on legal matters to support business operations and decision-making. Conduct research and analysis to stay updated on changes in laws and regulations that may impact the company. Collaborate with cross-functional teams to ensure compliance with legal requirements. Develop and implement effective legal strategies to mitigate risks and protect the company's interests. Stay current with industry trends and developments in law and regulation. Job Requirements Strong knowledge of legal principles, practices, and procedures. Excellent drafting and negotiation skills for complex legal documents. Ability to analyze complex legal information and provide clear and concise advice. Strong communication and collaboration skills to work effectively with stakeholders. Proficient in using legal software and technology to manage documents and data. Strong attention to detail to ensure accuracy and quality of legal work.
Posted 1 week ago
7.0 - 12.0 years
8 - 12 Lacs
Noida
Work from Office
Develop detailed project plans including scope, objectives, timelines, and resource requirements. Collaborate with engineering teams to ensure technical requirements are clearly defined and met. Required Candidate profile Lead and motivate cross-functional project teams, fostering a collaborative environment. Manage team performance, provide guidance, and support professional development.
Posted 1 week ago
12.0 - 22.0 years
25 - 30 Lacs
Bengaluru
Work from Office
Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Sr Mgr Regulatory Affairs Date: Jul 18, 2025 Location: Bangalore, India, 560064 Company: Teva Pharmaceuticals Job Id: 62865 Who we are The opportunity Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. Support team members with complex issues as a senior expert (especially in responsibilities 2 6). Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership. How you ll spend your day Department Leadership Organize and coordinate departmental tasks, personnel management, and planning. Manage budget and resource planning. Establish efficient internal and cross-departmental processes. Lead projects related to labeling, including project management. Review and approve SOPs for the department and overall processes. Support division leadership and develop strategy, principles, and guidelines. Team Leadership Organize and coordinate team tasks, personnel management and planning. Plan team activities and align with other teams. Labeling Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update) Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monitoring Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Pharmacovigilance Assess need for updates based on Company Core Safety Information (CCSI). Implement PV-triggered and non-PV-triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc. ) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA. Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Participate in project teams to fix the regulatory strategy and prepare expert statements. Respond to authority deficiency letters in collaboration with other departments. Mock-ups Coordinate creation and approval of packaging mock-ups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Industry Representation Participate in working groups (e. g. , Medicines for Europe) to represent the company as an EU labeling expert. Your experience and qualifications Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph. D. Additional leadership qualification is preferred. Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required. The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
7.0 - 10.0 years
19 - 22 Lacs
Bengaluru
Work from Office
We are looking for a highly skilled and experienced Legal Counsel to join our team at Vakilsearch, responsible for providing legal expertise and guidance on transaction advisory and corporate legal matters. The ideal candidate will have 7-10 years of experience in the field. Roles and Responsibility Provide legal counsel on transaction advisory and corporate legal matters. Draft and review contracts, agreements, and other legal documents. Conduct legal research and analysis to support business decisions. Collaborate with cross-functional teams to ensure compliance with laws and regulations. Develop and implement legal strategies to mitigate risks and protect company interests. Stay updated with changes in laws and regulations affecting the industry. Job Requirements LLB degree from a recognized institution. Minimum 7 years of experience in corporate law or a related field. Strong knowledge of corporate law, contract law, and regulatory frameworks. Excellent analytical, communication, and problem-solving skills. Ability to work independently and as part of a team. Strong attention to detail and organizational skills.
Posted 1 week ago
4.0 - 5.0 years
7 - 8 Lacs
Mumbai, Navi Mumbai
Work from Office
Regulatory Affairs Associate II Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate II Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work with minimal supervision and possess a thorough understanding of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents with all relevant departments Some experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities Establish and maintain SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA s Electronic Submission Gateway Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT Work closely with external departments, including CMC and the Device team, to align with internal product/device strategy and process Work closely with Regulatory Operations, as well as in Teva s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective Attend assigned project meetings to ensure labeling timelines are met Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling Work in a team environment with minimal supervision Perform all other job-related duties as required by management and dictated by process changes Your experience and qualifications Bachelors in pharmacy/masters in science & Life sciences - 4-5 Years in the Pharmaceutical Industry Masters in pharmacy - 3-4 Years in the Pharmaceutical Industry Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry Be able to multi-task in a fast-paced work environment Have exemplary oral and written communication skills Be organized with keen attention to detail Have the ability to work independently as well as in a team environment with minimal supervision Have knowledge of US FDA regulations and guidance related to US Gx labeling Have knowledge of US FDA regulations and guidance related to US drug listing Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions to the FDA PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel Adobe Acrobat Professional is a must Familiarity with TVT preferred Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
10.0 - 15.0 years
12 - 16 Lacs
Bengaluru
Work from Office
Mgr RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr RA EU Generics Labeling Jul 18, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Determination of an implementation plan and tracking the implementation of updates due to new requirements (e. g. new excipients warnings, QRD template update). Providing instructions and guidance to local RA (e. g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal/guidance changes affecting product information. Assess need for updates based on Company Core Safety Information (CCSI). Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Participate in project teams to fix the regulatory strategy and prepare expert statements. Respond to authority deficiency letters in collaboration with other departments. Coordinate creation and approval of packaging mockups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Assist with training new team members Your experience and qualifications Experience: 10+ years of total experience and minimum 6 to 7 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs. Education: Completed at least 8-semester university degree in natural sciences (e. g. , Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a PhD. Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs. Already Working @TEVA The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Posted 1 week ago
2.0 - 7.0 years
2 - 6 Lacs
Gurugram
Work from Office
We are looking for a skilled Assistant Manager to join our Accounting and Reporting consulting team at Uniqus Consultech. The ideal candidate will have 2-7 years of experience in accounting and reporting, with excellent analytical and problem-solving skills. Roles and Responsibility Manage and oversee the preparation of financial reports and statements. Develop and implement effective accounting procedures and policies. Analyze financial data to identify trends and areas for improvement. Collaborate with cross-functional teams to achieve business objectives. Ensure compliance with regulatory requirements and industry standards. Provide expert advice on accounting and reporting matters to clients. Job Requirements Strong knowledge of accounting principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment. Effective communication and interpersonal skills. Proficiency in accounting software and systems. Strong attention to detail and organizational skills.
Posted 1 week ago
2.0 - 7.0 years
8 - 11 Lacs
Surat
Work from Office
Elite Overseas Education Consultant is looking for Europe Counselor to join our dynamic team and embark on a rewarding career journeyDeveloping and implement an all-encompassing counseling plan.Conduct group or individual counseling sessions.Excellent communication skills and high emotional intelligence abilitiesExcellent problem-solving and critical thinking skills
Posted 1 week ago
2.0 - 5.0 years
4 - 7 Lacs
Bengaluru
Work from Office
Regulatory Monitoring & Analysis: Continuously monitor, track, and analyze new and evolving policies, regulations, rules, tariff orders, grid codes, and standards issued by central (e.g., MoP, MNRE, CEA, CERC) and state-level authorities. Required Candidate profile • Permits, Licenses & Approvals Management (Project Lifecycle): Manage the end-to-end process of obtaining all required licenses, permits, and approvals for solar, wind, and hybrid power projects.
Posted 1 week ago
3.0 - 5.0 years
4 - 6 Lacs
Gurugram
Work from Office
1. Connect top specialist doctors across India. 2. Focus on Phase 4 clinical trials and Post-Marketing Surveillance (PMS) 3. Ensure compliance and registration for clinical trials 4. Conduct medical survey for research & strategy purpose
Posted 1 week ago
8.0 - 13.0 years
5 - 10 Lacs
Pune
Work from Office
Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Senior Chemist in the Pharma Manufacturing Industry located in Vatva, Ahmedabad, your role will involve utilizing your M.Sc. in Organic Chemistry and 5 to 8 years of experience in API / Intermediates manufacturing within the pharmaceutical sector. Your responsibilities will include hands-on experience in the synthesis of APIs and intermediates, conducting literature searches using platforms such as SciFinder, Chemical Abstracts, Free Patent Online, and Journals. You will be involved in feasibility studies, route selection for synthesis, multi-step synthesis, yield improvement, and cost reduction strategies. Additionally, you will be responsible for tasks such as extraction, purification, distillation, lab validations, process development with strong documentation including Tech reports, process safety reports, and cost sheets. Furthermore, you will lead technology transfer from the laboratory to kilo lab and plant scale, while coordinating with IPR, Regulatory Affairs, and QA departments. Proficiency in tools like Chemdraw / Chemsketch is essential for this role. Please note that only male candidates from the Pharma Manufacturing Industry will be considered for this position. If you are seeking a challenging full-time, permanent role that requires your expertise in organic chemistry and pharmaceutical manufacturing, we look forward to receiving your application. With Regards, Himani(HR) 9377165778,
Posted 2 weeks ago
6.0 - 10.0 years
7 - 12 Lacs
Ludhiana, Mohali, Chandigarh
Work from Office
Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quality standards are met and submissions meet strict deadlines. Maintain high levels of accuracy, meet tight deadlines. Management of Data. Required Candidate profile Candidate should have min 6 yrs. of experience in Regulatory Affairs Experience in Domestic Markets. Candidate should be well versed with Drug Regulatory Compliances. Can handle or manage a team. Candidates should be able to review artworks related to Drugs. Candidate should have good knowledge about Legal Metrology regulations. Kindly note we are looking candidate who can join on immediate basis. Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129
Posted 2 weeks ago
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Accenture
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