Regulatory Affairs Executive 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.

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

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

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 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.

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

We are Urgently Looking for Regulatory Affairs Executive. Assisting Role in Ra Team and Responsible to Filings,

Vega Biotec Pvt Ltd forms part of Vega group companies having state of the art manufacturing company in Vadodara and having presence in over 20 countries. Our export arm has an opening for the following post.1. Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,B.pharma/M.pharmaExperience- Minimum 4 years in RAJob Profile-1. CTD or ACTD dossier preparation for ROW market.2. Coordinating with internal assistant team members for ongoing QA related work.3. Meeting regulatory requirements as per country requirements.

Studying Scientific and Legal Documentsmaintaining Familiarity with Company Product Rangesoutlining Requirements for Labelling, Storage and Packagingproviding Advice About Regulations to Manufacturers/scientistswriting Comprehensible, User-friendly, Clear Product Information Leaflets and Labelspreparing Documentationcandidate is Qualified with B.pharma & M.pharmaknowledge of Iso13485, Qms & Ce Marking is Must.

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

Regulatory Affairs ExecutiveLocation: Vadodara, GujaratMust have Experience in Pharma Industry Must have experience in handling regulatory affairs for ROW market mainly Central and Latin America and Africa for Pharma Formulations. Preparation, Compilation & Review of Registration documents that include Administrative & Technical. Reviewing the technical documents provided by QA, QC, Production. Providing them the report of shortcomings & ensures them to correct the documents. Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data. Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation. Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies. Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames. Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner. Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team. Fill up customer questionnaires by collecting information from various concerned departments. You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time. Maintenance of the complete history of each drug product

We have vacancy for 2 Drug regulatory affairs executive Jobs in Pune for Freshers Educational Qualification : B.Pharma, B.Sc, M.Pharma, M.Sc Skill Drug Regulatory Affairs,pharmacology,quality assurance,Formulations etc.

Hi,we have an urgent vacancy in Regulatory Affairs for a pharmaceuticals company.experience - 2-12 yearsLocation - Ahemdabadinterested candidates, please share your resume or references on

We have vacant of 2 Drug Regulatory Executive Jobs in Pune, Maharashtra,Drug Regulatory Affairs,Export Documentation,Quality Assurance Leader, Experience Required : 1 Year Educational Qualification : B.Pharma, M.Pharma, M.Sc Skill Drug Regulatory Affairs,Export Documentation,Quality Assurance Leader etc.