2122 Regulatory Affairs Jobs - Page 50

Job Description Job Title: Risk Management SME Medical Devices Location: Pune Employment Type: Full-Time Experience: 10+ Years Industry: Medical Devices Job Summary: We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including RD, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards. Key Responsibilities: Lead and e...

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible Required Candidate profile RA role in medical device,US FDA,EU Bachelor degree in Medical,Mechanical,Electric Life Science/other healthcare related majors 8yrs exp for RA role in medical device/pharmaceutical industry

We are looking for a skilled Process Manager to join our team at eClerx Services Ltd., with 6-10 years of experience in the IT Services & Consulting industry. The ideal candidate will have a strong background in process management and excellent leadership skills. Roles and Responsibility Develop and implement efficient processes to enhance productivity and quality. Manage and monitor existing processes to identify areas for improvement. Collaborate with cross-functional teams to align processes with business objectives. Analyze data to measure process performance and make informed decisions. Implement changes to improve process efficiency and reduce costs. Ensure compliance with industry sta...

We are looking for a dynamic and detail-oriented Trainee Engineer to join our Compliance and Certification team. You will serve as the communication bridge between our company, manufacturing clients, testing laboratories, and government authorities. Your role involves assisting companies in navigating compliance requirements for products, factories, imports, and exports. Education : - Graduate/Postgraduate in Environmental Science, Business Administration, MBA, Compliance, or relevant field Strong analytical and organizational skills Excellent written and verbal communication Attention to detail and ability to multitask Proficient in MS Office (Word, Excel, PowerPoint) Basic understanding of...

We are looking for a highly skilled and experienced Analyst to join our team in the IT Services & Consulting industry. The ideal candidate will have 6-8 years of experience in KYC analysis. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and ensure compliance with regulatory requirements. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to resolve complex issues and improve overall process efficiency. Provide expert guidance on KYC procedures and best practices to junior team members. Stay up-to-date with changes in regulations and industry standards related to KYC....

Role & responsibilities Understanding the methodology and factors involved in setting electricity tariffs, ensuring fairness and compliance with regulatory standards Staying informed about the laws, guidelines, and policies governing electricity Tariffs to ensure adherence and regulatory compliance Familiarity with the legal framework governing the generation, transmission, distribution, and consumption of electricity within the jurisdiction Hands-on experience in the Power / Infrastructure sector on all regulatory matters with good knowledge of electricity laws Dealing with Government Agencies for obtaining favorable orders for the company

Role & responsibilities - IPR patent evaluation - Selection of route of synthesis with costing. - Well know about updated guideline of Nitrosamine and GTI - Expert in multi-step organic synthesis - Expertise in plant equipment selection, product / process stabilization - TTD preparation - Expertise in characterization (1H, 13C, H5M5, DSC, TGA, ARSST) - Expertise in Impurity synthesis - Documentation required for cross functional team Preferred candidate profile ROS selection, characterization, Impurity synthesis

Role & responsibilities - IPR patent evaluation - Selection of route of synthesis with costing. - Well know about updated guideline of Nitrosamine and GTI - Expert in multi-step organic synthesis - Expertise in plant equipment selection, product / process stabilization - TTD preparation - Expertise in characterization (1H, 13C, H5M5, DSC, TGA, ARSST) - Expertise in Impurity synthesis - Documentation required for cross functional team Preferred candidate profile ROS selection, characterization, Impurity synthesis

Experienced in handling, management and expansion of product portfolios, markets/ territories Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc , but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) i...

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Experience 4 - 10 Years Industry IT Software - QA Testing Documentation Qualification M.Sc Key Skills Pharmaceutical Agro Chemical Quality Assurance Quality Assurance Analyst QA MSC Chemistry Chemical Agrochemical Quality Agreement GMP Guidelines

Key Responsibilities: Approvals and Clearances: Manage and secure all necessary approvals from state and central authorities, including: • DISCOMs, Transcos, CEIG, PTCC, Section 68, SLDC NOC, and synchronization approvals. • Transmission line schedules, tower/pole schedules, and other regulatory requirements for successful project commissioning. Regulatory Compliance: Conduct connectivity and feasibility studies for evacuation capacity in new projects. Ensure compliance with state and central regulations throughout the project lifecycle. Stakeholder Management: Liaise with government agencies, DISCOMs, and other regulatory bodies to expedite approvals. Address critical issues, identifying so...

Job profile Qualification : Bachelors Degree / Master Degree Industry Type : FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience : 10-12 years of relevant / equivalent experience Technical Skills : Building Services Generic Skills : Leadership, Communication, Vendor/people management, Strategies Behaviors : Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible...

-Work with the marketing department to develop marketing strategies and materials Work closely with the medical information teams to make sure that information about all the companys products are available and current Provide support to regulatory affairs department for obtaining applicable product licenses Conduct analysis of competitors products as well as own product pipeline Work with medical technical writers for creation of marketing material, package inserts etc Participate in local and international meetings to represent the company Skills and Competencies: Excellent Leadership skills Negotiation skills Leadership skills Proactive Excellent communication skills Excellent knowledge of...

The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive. PRIMARY DUTIES & RESPONSIBILITIES: Supports footprints projects with the ability to multi-task Assembles and submits documents for global registrations with direct oversight from the RA team Ensures all deadlines are met, payi...

The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive. PRIMARY DUTIES & RESPONSIBILITIES: Supports footprints projects with the ability to multi-task Assembles and submits documents for global registrations with direct oversight from the RA team Ensures all deadlines are met, payi...

Berger Paints India Ltd ( British Paints Div ) is looking for Area Sales Manager - Prolink 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 whi...

107/108, Raheja Plaza, Shah Industrial Estate Opp. Yashraj Studio, Off Link Road, Andheri (W) Mumbai 400053, India Manager (Regulatory Affairs) JOB DESCRIPTION Manager (Regulatory Affairs) Mumbai (Andheri) but will involve travel to manufacturing locations Compensation + Perks Competitive and at par with industry standards Director or as designated by him BRIEF OVERVIEW OF THE POSITION As Regulatory Affairs Manager, you are responsible for ensuring that all products and processes comply with national and international regulations, laws, and standards. This role is crucial for maintaining legal compliance, facilitating product approvals, and protecting public health and safety. JOB DESCRIPTIO...

Ensuring Products and facility comply with relevant regulations and Law Prepare documents Liaison with regulatory agencies External Audit Product registration dossiers, clinical trial documentation COPP product wise approval Required Candidate profile Strong Effective communication skills including writing and presentation skills Qualification M Pharm , MSc only preferred Location Kolkata, Pharmaceutical Factory

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc.- Chemistry with 5+ years of experience in Regulatory Affairs in International Business preferably in Agrochemicals Industry. Able to analyze complex Regulatory data. Regulatory follow up with CROs to ensure timely completion of studies. Required Candidate profile Plan, implement, monitor & lead GLP data generation activities for the registration of products in overseas markets such as USA, Brazil, etc. Support international registration activities. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc.- Chemistry with 5+ years of experience in Regulatory Affairs in International Business preferably in Agrochemicals Industry. Able to analyze complex Regulatory data. Regulatory follow up with CROs to ensure timely completion of studies. Required Candidate profile Plan, implement, monitor & lead GLP data generation activities for the registration of products in overseas markets such as USA, Brazil, etc. Support international registration activities. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience