Require Regulatory Excellence Senior Managers at Merck Limited
Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd. Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.
Post : Regulatory Excellence Center (Senior) Managers
• Excellent knowledge of global pharmaceutical legislation
• Experience with life-cycle management activities
• Practical experience in one of the following areas is preferred: submission project management, CMC, Labelling and artworks, including authoring of some parts of the dossier, preparation of answers to HA questions, PV, QA
• Awareness of regulatory affairs contribution to Pharma business
• Good experience with various Regulatory IT applications: DMS, RIM systems, Publishing and validation tools, e-portals
• Strong experience with various MS applications: Word, Excel, Power point, SharePoint, Outlook
• Strong experience in recruiting and onboarding new team members
• Solid people and resource management experience: performance management, development, retention, motivation, training, mentoring, resource planning, change management
• Excellent written and spoken communication skills in English
• Very good interpersonal skills and flexible mindset, ability to promote the same within the team
• Ability to set teams and to drive the teams confidently through the changes
• Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement
Complexity: The (Senior) Managers will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. Positions may provide an exposure to a communication with external stakeholders as well (i.e. CMOs, Vendors, Health Authorities). The (Senior) Managers will have themselves to work on complex tasks and to propose solutions and strategies, and as well to support the own subordinates in delivering the same in their day to day work.
Accountability and Independence : As Team leaders, the (Senior) Managers will hold the accountability for the team performance and will guide the teams accordingly. Positions will work closely with the Project and product managers to define and communicate the expectations to the own accountability of each team member, the interdependencies and to set strict criteria on the quality of the deliverables of each employee.
• Minimum M.Sc degree in a Life Science or a related discipline, higher degree is preferable (e.g. PhD in a scientific discipline). An advanced training in Business related discipline will be a strong advantage.
• 13-15 years of pharmaceutical industry experience, with at least 5 years in the Regulatory Affairs area, and minimum 5 years of people management experience (small to mid-size teams)
Experience : 10+ years
Location : Bangalore
Qualification : M.Sc
Industry Type : Pharma
Functional Area : Regulatory Excellence
End Date : 10th March, 2020
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