Business Development Manager -- As the name suggests, the individual with this designation will perform multiple functions but is primarily responsible to increase the annual revenue of the organization through the sale of products and services offered by the company. Gepach is looking for individuals who have the experience of selling branded & unbranded generics in the markets of CIS countries or GCC countries or countries in Central & Latin America or European countries or countries of Africa. Role & responsibilities The candidate will be responsible to prepare a business case consisting of sales forecasts, marketing activities, manpower requirements etc. for each country based on his/her experience and data available from relevant sources. The individual will be responsible to build a strong distributor network to gain entry to the markets with the products of the company. The individual will be responsible to register the products in the selected markets and arrange any necessary audits of the manufacturing site. The candidate will be accountable for the sales of the products and the implementation & execution of the marketing plans of the company in the assigned territories. The job involves extensive travel to various destinations for business development. The position requires an individual to be able to assess the market needs, identify new & developing opportunities for increasing market share, introducing new products, increasing revenue and growing the size of the business. The selected individual will build long lasting customer relationships and service the customers needs. The candidate will be responsible to coordinate between various teams within the company to achieve his business goals. Requirement :Fluency in local language and Experience in handing International Markets/ Africa/West Africa/ South East Asia/ Latin America markets would be an added advantage.Preferred candidate profile We are looking for confident individuals with high integrity, moral values and ethics. Positive energy, enthusiasm, and a drive to succeed are some of the personality characteristics that we seek in the candidates. The candidates should have good interpersonal skills and be able communicators. The candidates should have demonstrated problem solving capability and adaptability to unexpected scenarios in their previous roles.The individual should be a self-starter, resourceful, risk taker, seeking an opportunity to grow into a senior role in the near future. Perks and benefits Higher Salary Offered, based on potential

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.Gathering of technical information from various sources.Preparation of Dossiers, Submission of dossiers. Preparation of applications to regulatory bodies for all necessary approvals. FDA, CDSCO, international regulatory bodies.Review of dossiers of pharmaceutical productsAnswering queries of regulatory bodies connected with product registration.Overseeing of the regulatory process filing necessary applications and handling all government interactions. Coordinating the inspection of the organization facilities and contract facilities, and developing procedures to ensure regulatory compliance. Managing subordinate staff in the day-to-day performance of their jobs. Ensuring that project/department milestones/goals are met while adhering to approved budgets. Accompanying development projects and revising already existing technical documentations.Communicating with responsible regulatory authorities (national/international) as well as with notified bodies. Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of pharmaceuticals products and nutritional supplements. Training team members to fulfill their job functions and improving their skills. Staying informed about any changes in legislation etc.Skills needed Indian FDA guidelines knowledgeUnderstanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU.Organizational Skills- Work assignment, time management, working within strict time frames.Ability to solve regulatory queries & compliance matters.Knowledge of dossier types and filing requirements. Responsibilities of a Regulatory Executives / Officers :To prepare and compile registration dossier as per the specific country guidelines and submit to regulatory authorities.To prepare, review compile re-registration documents.To prepare & review /check artwork, pack insert, SmPC etc.To study Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.To verify specification of excipients, active, finished product and packaging material and all required documents.Application, review, co-ordination, follow-up of legal documents COPP, FSC etc.Maintain Proper database w.r.t to master document dossier.To collect and verify all technical documents and information from various departments at the manufacturing site.Provide Regulatory support to various departments.Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose.To reply any queries raised by respective regulatory authority, in timely manner.To maintain and update Registration certificate /information in regulatory data base. Requirement :Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country. Regulatory Affairs Manager - 5 +10 years experience of working in the regulated markets Regulatory Affairs Senior Executive / Officers - more than Two years experience in Pharma Regulatory Affairs will be preferred Required Candidate profile for Manager Level Effective oral and written communication skills. Must be flexible and capable of managing personnel Must have a systematic approach to solving problems. Must be able to keep calm and make quick, clear decisions while coping with pressure. Must be able to understand the techniques and processes used Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information. Must be organized- timely, and with information/data