Job Title:	Head of Regulatory Affairs
Market Sector:	Generics Company
Job Type:	Regulatory Affairs
Location:	India
Salary:	Competitive salary and benefits package with additional expatriate benefits negotiated as appropriate on an individual basis.
Reference:	5kjt2147
Consultant:	Keith Thrower
Background
Our client is a fast-growing, R&D-intensive and forward-looking chemicals manufacturer with a reputation for quality and innovation. In just over ten years, the company has grown from a single site company, supplying phase-transfer catalysts and other quaternary compounds, to a multi-site, global supplier of a diverse range of products, with turnover increasing from less than US$1 million in 1990 to almost US$30 million in 2004. The company is one of the leading bulk drug suppliers in India, and this activity represents about 20% of its business. Process R&D and contract manufacturing account for about another 40%, with the remaining 40% covering a wide range of speciality products and activities. It is essential for the future success of the company that the company's facilities, equipment, processes and products meet international regulatory requirements so that materials can be marketed worldwide, especially in the USA and Europe. The company is, therefore, building up its in-house expertise and resources in the regulatory, cGMP and validation areas so that it will be increasingly recognized as a truly global manufacturer and supplier. This new position is a key hiring for the company. The ideal candidate will have thorough knowledge of, and considerable experience of, regulatory affairs related to the manufacture and supply of a wide range of chemicals manufactured by Dishman, especially those used as active pharmaceutical ingredients (APIs). He/she will manage local regulatory activities in India, including strategy development and implementation, and the compilation, submission and maintenance of the appropriate dossiers (including the compilation, submission and maintenance of Drug Master Files (DMFs) to regulatory agencies worldwide, including the USA and Europe. He/she will also contribute to devising and implementing regulatory strategies relating to such things as ICH guidelines (eg guidelines Q8, Q9, Q10), process analytical technology, and any modern manufacturing philosophies adopted by the company, such as, for example, Real Time Release, 6 Sigma, Lean Manufacturing, etc.
The Job
To develop the company's strategy for Regulatory Affairs as a key driver of the business. To identify and provide internal guidance on regulatory submission content, and company policy responses to changes in regulations and guidelines impacting CMC, Development and Manufacturing Operations, educating clients, as appropriate. To maintain the company's Indian FDA licence and amendments for new products and facilities; act as the FDA Responsible Head. To work with R&D and Production personnel to ensure that correct and necessary data are provided to support new and existing regulatory filings; this will require a high level of technical understanding and strong project management and time keeping skills. To keep up-to-date on trends and changes in regulatory affairs that may affect the company (e.g. new ISO9002 standard) and alert senior management and colleagues when appropriate. The position has managerial responsibility for a small regulatory team.
Candidate Requirements
The successful candidate will ideally meet the following criteria: Essential: Degree or equivalent in chemical or pharmaceutical sciences. A proven track record of all aspects of Regulatory Affairs relating to the manufacture and supply of APIs. Broad experience of regulatory and QA requirements in the chemical and pharmaceutical industries. Successful leadership of inspections by the FDA and other recognised regulatory agencies and, preferably, by clients. Several years' management experience, with proven effective man-management skills, showing leadership qualities, and the ability to manage and work within a multicultural environment. Desirable: Higher degree in synthetic chemistry, process chemistry or a related area. Experience of manufacturing and/or QC operations and a broad knowledge of cGMP. Background knowledge of regulatory affairs relating to the development and marketing approval of pharmaceutical products, especially generics. Personal Qualities: Proactive, decisive and strongly focused on seeing projects through to successful completion. Able to work independently and as a member of multicultural teams. Good oral and written communication skills, including fluency in English. Able to deal with outside agencies and customers at all levels. Willingness to travel internationally.