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3 - 5 years
5 - 9 Lacs
Hyderabad
Work from Office
Overview Shure is a global leader in professional audio electronics with a history of product innovation spanning over 90 years. The Shure Hyderabad location has been operational since June 2019. W e are looking for talented professionals who have experience in the SEZ compliance area. This position is a part of the Finance team at Shure India. Responsibilities Well versed with SEZ Rules , Regulations and customs regulation Should have exposure to de-bonding, Imports, DTA, Temporarily Removal of goods and other allied matters in SEZ Well versed of SEZ online portal Exposure to all compliances related to SEZ and STPI units viz., MPR, QPR, APR, Softex, Endorsement of Invoices, DSPF etc. Collation of details from relevant teams for preparation of returns/ submissions/ replies to SEZ STPI authorities for various units across India Responsible for representations/liaising with SEZ/STPI Authorities for various matters and obtain necessary approvals Assistance in audits Liasioning with Bankers for clearing the BOE’s Ensuring the invoices are in compliance with the SEZ norms Maintaining the documentation Maintaining the Fixed Asset Register Qualifications Bachelor’s Degree in Commerce or MBA with experience of working in multi national companies in similar role. Experience is minimum 3Years. WHO WE ARE. Shure’s mission is to be the most trusted audio brand worldwide – and for nearly a century, our Core Values have aligned us to be just that. Founded in 1925, we are a leading global manufacturer of audio equipment known for quality, reliability, and durability. We engineer microphones, headphones, wireless audio systems, conferencing systems, and more. And quality doesn’t stop at our products. Our talented teams strive for perfection and innovate every chance they get. We offer an Associate-first culture, flexible work arrangements, and opportunity for all. Shure is headquartered in United States. We have more than 35 regional sales offices, engineering hubs, and manufacturing facilities throughout the Americas, EMEA, and Asia. THE MIX MATTERS Don’t check off every box in the job requirements? No problem! We recognize that every professional journey is unique and are committed to providing an equitable candidate experience for all prospective Shure Associates. If you’re excited about this role, believe you’ve got the skills to be successful, and share our passion for creating an inclusive, diverse, equitable, and accessible work environment, then apply! #LI-HYBRID
Posted 2 months ago
8 - 13 years
20 - 25 Lacs
Varanasi
Work from Office
Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status
Posted 2 months ago
0 - 2 years
5 - 8 Lacs
Noida
Work from Office
Career County is looking for LEGAL EXECUTIVE to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.
Posted 2 months ago
1 - 2 years
2 - 3 Lacs
Mumbai
Work from Office
Vital Healthcare Pvt. Ltd. is looking for Officer Regulatory Department to join our dynamic team and embark on a rewarding career journey. Oversee and manage daily operations within the assigned department Ensure compliance with company policies, industry regulations, and legal standards Prepare reports, maintain records, and handle documentation efficiently Coordinate with internal teams and external stakeholders for smooth workflow Address and resolve operational challenges to improve efficiency Monitor performance metrics and implement corrective actions when necessary Support senior management in decision-making and strategic planning
Posted 2 months ago
3 - 8 years
3 - 6 Lacs
Ahmedabad
Work from Office
Role & responsibilities: Compilation and review of registration dossiers as per Country specific guidelines and requirements. Specific experience required for Latam American market including Brazil, Mexico. Should have to work for EU market and hands on experience about the submission Management system. Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) Compilation of deficiency responses of new product submission and Backlog dossier To review the proposal for any post-approval changes as per the current regulatory guidance. To prepare and submit the variation for post approval changes. To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. To review various artworks & comments for ongoing commercial supply & products for the new launch. To prepare and maintain various registration Data base & updating at Central Depository. Preferred candidate profile: Candidate must have core International Regulatory Affairs experience in Latam and EU market can only apply. Candidate should have good technical job knowledge of EU and other regulatory. Should have good communication and interpersonal skills
Posted 2 months ago
4 - 7 years
4 - 6 Lacs
Gurgaon
Work from Office
Job Title: Senior Executive Drug Regulatory Affairs (DRA) Job Responsibilities: Prepare and review regulatory dossiers in compliance with country-specific guidelines, including CTD, ACTD, and other regional formats. Manage dossier submissions for new registrations, re-registrations, and product variation filings. Review quality and administrative documents to ensure completeness and accuracy before submission. Conduct literature searches to compile non-clinical and clinical data for dossier preparation. Develop and review SmPCs, Package Inserts, and labeling information in accordance with regulatory requirements and initial dossier submissions. Evaluate and approve artwork for export products. Collaborate with cross-functional departments including QA, QC, Production, ADL, and R&D to streamline regulatory processes. Address and resolve queries from regulatory authorities such as the FDA and other relevant agencies. Maintain communication with international clients regarding dossiers, sample requirements, and regulatory updates. Draft and review applications for product permissions, COPPs, and FSCs. Market Exposure: ASEAN: Philippines, Vietnam, Myanmar, Laos, Cambodia, Thailand Africa: Uganda, Nigeria, Ethiopia, Mozambique, Tanzania, Cameroon, Ivory Coast, Benin, Burundi, Togo, Congo, ZaZiBoNa, South Africa LATAM: Peru, Ecuador, Bolivia, Guatemala, Nicaragua, Costa Rica CIS: Kyrgyzstan, Uzbekistan, Russia, Ukraine Other Regions: Georgia, Sri Lanka, Azerbaijan
Posted 2 months ago
10 - 14 years
12 - 16 Lacs
Bengaluru
Work from Office
Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary – To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the standard contracts templates and procedures for complex buyside deals in accordance with changing laws and company policies. Develop specialized subject-matter expertise in support area to seamlessly address any potential risks or issues.Complexity: Requires identifying and assessing complex problems for area of responsibility. Creates solutions in situations in which analysis requires an in-depth evaluation of variable factors. Requires adherence to strategic direction set by senior management when establishing near-term goals. Interaction is with senior management of the team, internal stakeholders third party vendors, contractors subcontractors etc., involving matters that may require acceptance of an alternate approach..Authority:Some latitude in decision-making. Acts independently to determine methods and procedures on new assignments.Impact or Decision Impact:Decisions have a major day to day impact on area of responsibility.Scope:Manages large - medium sized teams and/or work efforts (if in an individual contributor role).Relationships:Supervises:?Team members providing services on a process/project or account/portfolio of accountsExternal Relationships:?Procurement, Business Executives, Contract Management, Outside counsels, Vendors, Corporate Function related stakeholders like HR, Workplace etc. What are we looking for? Bachelor's degree in LawCertifications and Membership:?Contract related global professional certification considered a plusWork Experience:?Minimum of 5 to 15 years of experience at law firm or as in-house counsel and/or in legal outsourcingKnowledge and Skill Requirements: Expert level understanding of both commercial and legal contractual risks and displays ability to provide business-oriented legal advice Fluent in English with strong oral and written skills Experience in managing end-to-end projects and teams on function specific processes and/or areas, work with internal and external teams, and understands delivery requirements Demonstrate excellent interpersonal skills, is detail-oriented, has sound judgement, is adaptable, demonstrate promptness, accuracy, and consistency with the activities supported, and drive tasks to closure, has strong time management, prioritization, organizational skills Build trust-based relationships by delivering on commitments, ability to work under pressure, with exposure to senior management Effectively manage priorities and stakeholder expectations Able to effectively influence senior management. Good understanding of Accenture offerings and function specific services performed, very good understanding of commercial agreements, legal and compliance fundamentals, corporate business practices, and contracting regulations Comfortable with technology and has experience in the use of tools & databasesBehaviours and Attributes: Open to work with and understand cross-cultures and locations throughout Accenture global organization Understand the value of diversity and recognize the strengths that different styles, innovative perspectives and experiences bring to Accenture Demonstrate inclusion and respect for all individuals regardless of gender, race, ethnicity, religion, belief, age, disability, culture, social status and/or sexuality Leader as well as team player, collaborative and persuasive; able to work well with executives and non-executives.Work Requirements:?Travel may be required Fluency in English (and other language, depending on geography supported) with very strong oral and written communication skills. Roles and Responsibilities: Generic Responsibilities Qualifications Any Graduation
Posted 2 months ago
1 - 3 years
3 - 5 Lacs
Bengaluru
Work from Office
Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model – powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for? Collaboration and interpersonal skills Problem-solving skills Strong analytical skills Numerical ability Ability to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom
Posted 2 months ago
5 - 8 years
7 - 11 Lacs
Bengaluru
Work from Office
We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets. Roles & Responsibilities: Dossier Preparation and Review: Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing. Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements. Agency Communication and Submission: Develop and submit quality responses to agency queries within specified timelines. Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents. Documentation and Compliance: Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements. Prepare, update, and review product labeling and information. Cross-functional Collaboration: Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation. Manage notifications and documentation for implementation of amendments. Regulatory Process Management: Ensure documentation practices align with organizational and regulatory standards. Maintain organized and accurate records for all regulatory activities.Role & responsibilities Requirements: Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm). Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets. Proficiency in electronic publishing tools and CTD/eCTD dossier formats. In-depth understanding of South Africa-specific regulatory guidelines. Strong organizational, communication, and documentation skills. Ability to prioritize multiple projects and meet strict deadlines. Collaborative team player with a proactive and detail-oriented mindset.
Posted 3 months ago
10 - 20 years
10 - 20 Lacs
Bengaluru, Visakhapatnam, Hyderabad
Work from Office
• Accountable & responsible for business development activities carried out according to corporate strategy • Responsible for overall revenue growth - Planning and achievement of annual target volumes, new market strategy, process validation & regulatory filing & customer management • Involved in product registration related to regulatory compliance and documentation • Responsible for coordination with internal, external & regulatory stakeholders • Grow business in area of influence by selecting and developing approved new Suppliers and wholesalers • Broadening the product range/volume in the existing customer base • Explore tender/rate contract opportunities in potential institutions and ensure timely communication to sales manager • Identify new partners in the existing territories • Discover new territories & partners • Support in identifying new potential products in existing as well as new territories
Posted 3 months ago
2 - 5 years
3 - 8 Lacs
Gurgaon
Hybrid
Job Summary:- Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a.Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc
Posted 3 months ago
5 - 10 years
4 - 9 Lacs
Panchkula
Work from Office
Role & responsibilities 1. Regulatory Submissions and Approvals: Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations). Maintain accurate and up-to-date records of regulatory documents, approvals, and communications. Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations. 3. Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities. 4. Product Development Support: Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies. 5. Regulatory Intelligence: Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations. 6. Communication and Coordination: Act as a point of contact between the company and regulatory bodies in the assigned markets. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches. 7. Cross-functional Collaboration: Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information. 8. Product Registration Lifecycle Management: Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments. Ensure timely submission of regulatory documents to maintain product approvals and licenses. 9. Risk Management and Problem-Solving: Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions. Preferred candidate profile Must have experience in Injectables dosage forms. Perks and benefits
Posted 3 months ago
7 - 12 years
7 - 14 Lacs
Panchkula
Work from Office
Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.
Posted 3 months ago
3 - 5 years
5 - 7 Lacs
Bengaluru
Work from Office
Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy
Posted 3 months ago
2 - 6 years
3 - 4 Lacs
Vadodara
Work from Office
RA Ensure compliance with regulations,prepare & submit regulatory filings, & maintain existing registrations,ensuring API & related products meet legal requirements.Must Knowledge of Dossier Making,Product Permission,Application Permission,ROW Market
Posted 3 months ago
0 - 2 years
1 - 2 Lacs
Bengaluru
Work from Office
Assist with regulatory compliance tasks for the firm. Research and stay updated on relevant financial regulations. Review client documentation and ensure adherence to KYC/AML procedures. Prepare reports and presentations on compliance topics. Maintain accurate records of compliance activities. Skills Strong attention to detail and accuracy. Ability to understand and interpret complex regulations. Excellent research and problem-solving skills. Strong work ethic and commitment to ethical practices.
Posted 3 months ago
4 - 8 years
0 - 0 Lacs
Bengaluru
Work from Office
Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and marketing teams to integrate regulatory considerations into the product development and commercialization processes. Regulatory Submissions: Oversee the preparation and submission of all necessary regulatory new dossier filings, and variations, to relevant health authorities in the targeted regions. Market Intelligence: Monitor and analyze evolving regulatory landscapes and market trends to proactively identify opportunities and challenges. Stakeholder Engagement: Build and maintain strong relationships with regulatory agencies, industry associations, and key stakeholders to facilitate smooth regulatory processes. Team Leadership: Lead and mentor a diverse team of regulatory professionals, promoting a culture of excellence, compliance, and continuous improvement. Compliance Oversight: Ensure all regulatory activities adhere to internal policies and external regulations, managing audits and inspections effectively.
Posted 3 months ago
4 - 8 years
4 - 5 Lacs
Chennai, Pondicherry
Work from Office
Candidate job profile Qualification degree B. Pharm or M. Pharmacy and minimum 3 years experience in dossier preparation (Cis & Latam Market). Job Description Dossier Preparation & Compilation
Posted 3 months ago
10 - 15 years
4 - 9 Lacs
Bengaluru, Visakhapatnam, Hyderabad
Work from Office
• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements
Posted 3 months ago
4 - 7 years
6 - 10 Lacs
Aurangabad
Work from Office
Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.
Posted 3 months ago
10 - 14 years
12 - 15 Lacs
Mumbai
Work from Office
Well versed with regulatory requirements of Brazil, South Africa, Australia Able to deliver output in terms of registration approvals Experience in variation filings Good knowledge of CTD dossiers & publishing in above countries Documentation Review
Posted 3 months ago
13 - 16 years
12 - 17 Lacs
Navi Mumbai
Work from Office
Key Responsibilities: Preparation and submission of DMF (Drug Master Files) and other regulatory documents. Handling regulatory queries and compliance with global regulatory agencies. Coordination with R&D, QA, and production teams for regulatory submissions. Maintaining up-to-date knowledge of regulatory guidelines (USFDA, EDQM, TGA, etc.). Ensuring smooth regulatory approvals and post-approval compliance.
Posted 3 months ago
4 - 9 years
3 - 6 Lacs
Mumbai Suburbs
Work from Office
Fortpoint Hero is looking for Assistance Sales Manager to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status ,
Posted 3 months ago
4 - 9 years
3 - 6 Lacs
Virar
Work from Office
Fortpoint Hero is looking for Assistance Sales Manager to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status ,
Posted 3 months ago
3 - 6 years
4 - 8 Lacs
Ahmedabad
Work from Office
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
Posted 3 months ago
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