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 : Specialist / Senior Analyst Regulatory CMC
The Specialist Regulatory Affairs CMC (RA-CMC) is responsible for and contributes to driving assigned CMC regulatory activities including planning CMC Dossier generation for assigned submissions worldwide.
Role is responsible for ensuring companies compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
IMPACT : Impacts the results of own team or even influences a range of customer, operational, project or service activities of closely related teams with own contributions. Explains complex or even difficult/sensitive information to others in straightforward situations and interacts across business areas. May even advance discussions and build consensus across the business and with external parties regarding own technical area.
COMPLEXITY : Performs a range of routine or even non-routine assignments to solve problems of low to moderate complexity that require working knowledge and experience in own job discipline. Analyzes factual information and possible solutions to make independent judgement, recommendations and decisions. May also use best practices to improve products or services.
ACCOUNTABILITY/ INDEPENDENCE : Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance and direction within clear or even broad guidelines.
● Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyond.
● Minimum of 4 years of pharmaceutical industry experience
● Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
● Ability to understand and support the development of regulatory strategies and dossiers
● Experience in preparation and management of regulatory documentation, or variations
● Experience with life-cycle management activities would be an asset
● Practical experience in one of the following area for biotech or chemical molecules: manufacturing process development, transfers, validation or analytical development and quality management
● Knowledge of global pharmaceutical legislation
● Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
● Good interpersonal skills and flexible mindset
● Attention to details
● Ability to think strategically
● Ability to work in teams
● Project management
● Awareness of regulatory affairs contribution to Pharma business
● Good organizational and planning skills
Experience : 4 years
Location : Bangalore
Qualification : M.Sc, Ph.D
Industry Type : Pharma
Job Requisition ID : 202274
Functional Area : Regulatory CMC
End Date : 30th March, 2020
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