Regulatory Affairs Executive Job Vacancies in Gujarat

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.

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.

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

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.

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

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

M Pharm candidate Preferably done Internship in Regulatory Affairs Department with any Pharma Company / Chemical,/ Health Care Company.Experience: Minimum 6 months of work experience with Any Pharma Company in Regulatory Affairs Department.