Regulatory Affairs Jobs

Job Title:Medical Device Regulatory Affairs SpecialistBhopal LocationCompany: Intense Medical & Dental System Pvt Ltd Bhopal.Job Brief:We are looking for a skilled Regulatory Affairs Specialist to manage and coordinate regulatory compliance for our medical devices. This role requires strong communication with channel partners, collaboration with documentation teams, and ensuring all products meet regulatory standards for both domestic and international markets.______________Key Responsibilities:* Ensure medical devices comply with all applicable national and international regulatory requirements and standards* Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations* Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes* Monitor and interpret changes in medical device regulations and assess their impact on the company* Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development* Develop and implement regulatory strategies to support new product development and market expansion* Maintain organized, up-to-date documentation to demonstrate compliance and support audits* Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment______________Requirements:* Bachelors degree in Biomedical Engineering, or B.E electronic commination. or a related discipline* 34 years of experience in medical device regulatory affairs* Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.)* Excellent verbal and written communication skills* High attention to detail, analytical thinking, and problem-solving ability* Experience working collaboratively across multiple teams______________Preferred Qualifications:* Regulatory Affairs Certification (RAC)* Experience with Class II or III medical devices* Familiarity with quality systems (e.g., ISO 13485, FDA QSR)Key Responsibilities: Quality Assurance and Control Regulatory Compliance Process Improvement Supplier Quality Management Key Documentation and Reporting

Key Responsibilities: Ensure medical devices comply with all applicable national and international regulatory requirements and standards Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes Monitor and interpret changes in medical device regulations and assess their impact on the company Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development Develop and implement regulatory strategies to support new product development and market expansion Maintain organized, up-to-date documentation to demonstrate compliance and support audits Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment________________________________________Requirements: Bachelors degree in Biomedical Engineering, or B.E electronic commination. or a related discipline 3 - 4 years of experience in medical device regulatory affairs Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.) Excellent verbal and written communication skills High attention to detail, analytical thinking, and problem-solving ability Experience working collaboratively across multiple tea

Handle regulatory documentation and submissions for Pharmaceutical Products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and international regulationsEnsure products comply with all legal and regulatory requirements of India and specific export markets.Regulatory handling and submission Basic knowledge of LATAM & ROW market registration procedures Review product labels, artworks, and marketing materials to ensure regulatory compliance.

Regulatory AffairsQuality AssuranceISO 13485

Qualification / ExperienceBachelor's/Masters degree in Law (LLB/LLM) .3-7 years of experience in land acquisition matters, preferably in the renewable energy sector.In-depth knowledge of land acquisition laws, property registration, and regulatory approvals.Experience in dealing with government agencies, revenue departments, and local authorities.Fluency in Hindi, Marathi, English.Key Responsibilities:Conduct legal due diligence and verify all land records .Engage and liaison with landowners, government officials Lawyers & cross functional teams for land acquisition, approval and clearness, project finance and regulatory compliance.Manage and mitigate ROW disputes, and other legal disputes.Maintain a comprehensive database of land records & legal documentation and appraise the management on daily activity.

Key Responsibilities: Strategic Leadership: Develop and implement regulatory strategies for new and existing products, ensuring alignment with company objectives and global regulatory requirements. Submission Management: Prepare, review, and submit high-quality regulatory dossiers to regulatory agencies (e.g., FDA, EMA) for product registrations, variations, and renewals. Compliance Assurance: Monitor and interpret evolving regulations, guidelines, and standards to ensure ongoing compliance and proactively address potential risks. Collaboration & Communication: Collaborate effectively with cross-functional teams (R&D, Quality, Manufacturing) to provide regulatory guidance and support throughout the product lifecycle.Requirements: Regulatory Expertise: In-depth knowledge of global pharmaceutical regulations, guidelines, and standards (e.g., ICH, GMP). Strategic Thinking: Ability to develop and implement effective regulatory strategies aligned with business objectives. Communication & Collaboration: Excellent written and verbal communication skills with the ability to build strong relationships with internal and external stakeholders. Problem-Solving & Decision-Making: Analytical and problem-solving skills with the ability to make sound decisions in a complex regulatory environment. Leadership & Management: Proven ability to lead and motivate a team, providing guidance and support to achieve departmental goals.Education Required : Proven experience as a Regulatory Affairs Manager in the pharmaceutical industry. Strong understanding of drug development and manufacturing processes. Excellent knowledge of regulatory submission requirements and procedures

Ensuring compliance: Ensuring that a company's products comply with the regulations of the regions where they are distributedKeeping up with regulations: Keeping up to date with national and international legislation, guidelines, and customer practicesPreparing documentation: Preparing submissions for license variations and renewals, and other regulatory documentation

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We are urgently looking for Executive Regulatory Affairs . Handling of queries , CoPP , LOAs, Mockups, Handling of GS

Responsible for ensuring that all regulatory requirements for the manufacture, testing, and approval of injectable pharmaceutical products are met. This includes preparing and submitting regulatory filings to the relevant authorities, maintaining compliance with applicable laws and guidelines, and ensuring that the injectable products are developed and marketed in accordance with regulatory standards.

Position: Research And Development ApprenticeshipEligibility: LGBT Applicants Only + B.Pharm/M.Pharm (2022, 2023 or 2024 pass outs) + Bangalore City candidate***The above 3 parameters in Eligibility will be considered ONLY***Qualification: (2022, 2023 & 2024 Pass Outs) B. Pharm / M. PharmStipend: INR 25,000 per month (in hand)Duration: 12 monthsCTA: Depending on performance maybe be converted into full time resources at the end of the internship periodWork Timing, General Shift: 9AM to 5 PMLocation: Bengaluru OnlyWho Can Apply - LGBT+ (Lesbian, Gay, Bisexual, Transgender+) Pharma Job Seekers who are based in and around Bengaluru only Role Requirements-Good English language skills written and verbal particularly in scientific/medical terminologyAbility to evaluate data and draw conclusions with appropriate guidance from senior team members or managerGood attention to detailGood interpersonal, presentation and communication skillsService-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environmentComputer proficiency, IT skills, the expertise and ability to work with web-based applicationsGood level of flexibility and ability to prioritize workIf you belong from LGBT Community then please send CVs at pamela@thepridecircle.com

Position : Executive/Senior Executive - DRAExperience: Above 3 Years(API)Here we can source person from other countries(Regulatory Countries also) , except ROW Market(Semi Regulated Market)will not be preferred.Profile Exposure : US Export Market, DMF, Compliance, Queries handle.Qualification : B.Pharma/ M.Pharma/M.Sc.

responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

Should have worked for regulatory affairs, should have knowledge about regulatory guidelines, dossier preparation, should have exposure to solve regulatory queries,

Export Executive (Pharma) Job Responsibilities:Lead Generation: Identify and generate new buyer leads in international markets.Client Convincing: Engage with potential clients, present products, and convince them for sales.Documentation: Manage all export documentation, including regulatory, shipping, and compliance papers.Client Communication: Maintain regular communication with clients to ensure smooth transactions.Order Processing: Oversee the processing of international orders and ensure timely delivery.Compliance: Ensure adherence to global export regulations and pharma standards.Follow-up: Follow up on payments, orders, and customer feedback to build long-term relationships.Key Skills:Strong communicationClient relationship managementDocumentation & regulatory knowledgeMarket researchAttention to detailNegotiation skills

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Timely compile materials for license renewals, updates and registrations. Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners. Review labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory re-portability Responsible for timely registration of the facility Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required

After 45 days of free training (technical) followed by 15 days (non technical), candidates can be placed in pharma company. During training candidate need to take care of living expenses including food accomodation and local travel.

Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990. Kreative was established by Dr. S. Krishnamohan. Dr. Krishnamohan was formerly with TIFR, BARC, Caltech and NASA. He is a scientist of international repute and runs Kreative with professionalism and a focus on innovation.Kreative maintains strict quality standards and has developed a robust quality system around which all of our products are manufactured.Kreative invested in a state of the art cGMP facility in 2005 and expanded it to a US FDA class facility in 2013.Kreative, is WHO GMP certified and has been successfully been audited by the US FDA in Feb 2020.

Designation: Sr. Officer / Executive/ Sr. Executive (Regulatory Affairs USA, EU, JAPAN,ANVISA, TGA market)Experience:- 3 to 6 years' work experience in international and domestic Pharma regulatory affairs.- Confirmed knowledge of Global market regulatory requirements and ICH guidelines.- Should have experience in eCTD DMF/Dossier preparation and review including life cyclemanagement, specifically CMC writing & preparing module 1, 2 and 3 previously.- Should have experience in handling of changes notification to customers and agencies- Should have experience in renewal of facility registrations and drug listing activities.- He/she has to work independently. There is no scope for supervision or team handling.- Only M.Sc Chemistry preferably or complete experience in API industry for BPharm /MPharm .Job Responsibilities:- Preparing DMF/dossiers for regulated and semi-regulated markets.- Preparation of documents for domestic license permissions.- Gathering, evaluating, organizing and managing drug substances and intermediatesregulatory information in a variety of formats.- Handling of change notifications with the customers and regulatory agencies- Maintaining Regulatory database up to date.- Address customer complaints and queries within agreed timelines.- Attending various customer and health authority audits held at the manufacturing site- Keeping up-to-date with changes in regulatory legislation and guidelines- Writing comprehensible, user-friendly, clear process description and impurity profile- Ensuring that high quality standards are met and submissions meet strict deadlines.Primary Skills:Understanding on API process and analytical methods development flowKnowledge on impurity profile, analytical method validations and stability studies.Knowledge on eCTD submission structure.Fluency in oral and written English.Able to build and maintain good communication with cross functional departments