Regulatory Affairs Jobs

As a Regulatory Affairs Executive, you will be responsible for ensuring that our products meet regulatory requirements and standards. Your role will involve various tasks related to compliance and coordination with different departments.**Key Responsibilities:**- **Regulatory Submission Preparation:** You will prepare and submit regulatory documents to authorities, ensuring all submissions are complete and accurate to facilitate timely approvals.- **Regulatory Compliance Monitoring:** Regularly monitor updates and changes in regulations to ensure our products and processes remain compliant with industry standards and guidelines.- **Collaboration with Cross-Functional Teams:** Work closely with the research, quality assurance, and production teams to gather necessary information for regulatory submissions and to address compliance issues.- **Product Lifecycle Management:** Assist in managing the lifecycle of products, from development through registration to post-market surveillance, ensuring compliance throughout.- **Maintaining Regulatory Documentation:** Organize and maintain regulatory files and documentation, ensuring they are up-to-date and easily accessible for audits and inspections.- **Conducting Risk Assessments:** Evaluate potential risks associated with regulatory compliance and develop strategies to mitigate these risks effectively.**Required Skills and Expectations:**- A Master's degree in Pharmacy (M.Pharma) is essential, reflecting a strong foundation in pharmaceutical sciences.- Candidates should have 2-3 years of experience in regulatory affairs or related fields, demonstrating hands-on experience in managing regulatory processes.- Strong understanding of regulatory requirements, guidelines, and industry standards is crucial for ensuring compliance.- Excellent attention to detail and strong analytical skills to evaluate complex regulatory information effectively.- Good communication and interpersonal skills are necessary to liaise with various stakeholders and present regulatory submissions clearly and concisely.

We are seeking a dedicated and organized Regulatory Executive to join our team in Ahmedabad. The ideal candidate will play a crucial role in ensuring compliance with regulations and maintaining company standards.Key Responsibilities:1. **Regulatory Compliance**: Ensure that all company operations comply with relevant regulations and standards. This involves keeping up to date with regulatory changes and implementing necessary adjustments.2. **Documentation Management**: Prepare, review, and file regulatory documents accurately and promptly. This process is essential for maintaining organizational integrity and readiness during inspections.3. **Communication Liaison**: Serve as the primary point of contact for regulatory authorities. Effective communication is vital to address inquiries and ensure smooth interactions with regulatory bodies.4. **Risk Assessment**: Conduct assessments to identify potential regulatory risks and recommend solutions. This proactive approach helps to mitigate issues before they escalate.5. **Training and Support**: Provide training and guidance to team members on regulatory requirements. Sharing knowledge ensures that everyone is aligned with compliance expectations.Required Skills and Expectations:The ideal candidate should hold a postgraduate degree and possess 1 to 7 years of relevant experience in a regulatory role. Strong analytical skills, attention to detail, and excellent communication abilities are essential. Candidates must also demonstrate a proactive attitude and the ability to work collaboratively in a team environment. Being organized and having strong problem-solving skills will contribute to success in this role.

Develop and execute comprehensive marketing strategies and plans for assigned pharmaceutical products throughout their lifecycle.Conduct market research, competitive analysis, and customer segmentation to identify market opportunities and unmet needs.Collaborate with R&D, manufacturing, new business development, sales, and regulatory teams to ensure alignment and successful product launches.Manage product positioning, messaging, branding, and promotional activities.Monitor product performance, analyze sales data, and recommend adjustments to marketing strategies.Develop and manage the product marketing budget.Train and support the sales force on product knowledge and marketing messages.Ensure all marketing materials and activities comply with pharmaceutical industry regulations and company policies.

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.