Regulatory Affairs Job Vacancies in Ahmedabad

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.

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

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.

1) QMS (Change Control, CAPA, Deviation)(2) Process Validation(3) Equipment Qualification(4) Area Qualification(5) Cleaning Validation