Job Descriptions : 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 similar experience. 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.
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. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country of manufacture and export destinations. Coordinate with relevant regulatory authorities to resolve queries and ensure timely approvals. 3. Task Management and Timeliness Ensure timely completion of departmental tasks, adhering to internal and external deadlines. Prioritize assignments and allocate resources effectively to maintain productivity. 4. Compliance Assurance Ensure that all regulatory guidelines are strictly adhered to during product manufacturing and export processes. Stay updated on changes in regulatory requirements and communicate updates to the team. Coordinating the inspection of the organization facilities and contract facilities and developing procedures to ensure regulatory procedures to ensure regulatory compliance 5. Team Leadership and Development Supervise and mentor the regulatory affairs team, fostering a culture of collaboration and accountability. Conduct performance evaluations, provide feedback, and identify training needs for team members. 6. Documentation and Reporting Maintain accurate records of all regulatory submissions and approvals. Prepare regular progress reports for senior management, highlighting achievements, challenges, and solutions. Skills needed Indian FDA guidelines knowledge Understanding & 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 : Strong oral/written communication, leadership & problem-solving skills. Ability to stay calm under pressure and make quick decisions. Proficient in relevant techniques, processes, PC & internet research. Well-organized with timely data/information management.
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