Regulatory Affairs Specialist
Qualifications & Experience:
· B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
· Must have at least 4-6 years’ experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in regulatory affairs
· Conversant with various regulatory requirements for India, Sri Lanka, Bangladesh & Nepal with respect to medical device registration, import, clinical trials, etc.
· Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release
Attributes:
· Excellent communication and interpersonal skills - Good verbal communicator and presenter
· Customer focused: Understands and delivers customer service
· Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
· Good verbal and written communication skills in English - with colleagues, management and external authorities
· Self-motivated and positive "Can do" attitude. Can work autonomously but is also a team player
· Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
· Be able to plan, manage, organize and report in an efficient way
· Be independent, persuasive, innovative and able to summarize
· Good time management: Well organized, able to set and reset priorities
KEY TRAITS
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TRAITS |
STRONG INDICATORS |
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External Focus |
· Interacts regularly with customers and seeks inputs. · Well informed regarding market and industry / competitors operating in territory. · Initiates or champions changes from the outside in. · Explores new opportunities and asks informed questions. · Experience of dealing with various functions internally and externally |
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Execute |
· Consistently delivers results on time and exceeds expectations. · Ensures the processes are capable of achieving the desired direction · Clarifies roles and aligns resources allowing for faster execution. · Orchestrates resources for optimal use. Continually monitors progress and seeks continuous improvement. |
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Inspires Others |
· Has the ability to connect ,motivate, engage the sales force · Builds networks to obtain cooperation without relying on authority. · Makes active attempts to influence events to achieve goals · Establishing procedures to monitor the results of delegations, assignments, or projects; · Seeks and values different perspectives and ideas to foster an inclusive work environment |
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Clear Thinking |
· Understands strategic contexts, identifies opportunities · Is able to anticipate risks, evaluate options and defines priorities for the team · Establishing a course for self and for others to accomplish a specific goal; planning proper assignments of personnel and appropriate allocation of resources. · Committing to an action after developing alternative courses of action that are based on logical assumptions and factual information and that take into consideration the resources, constraints and organizational values. |
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Mission values |
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Compliance & Integrity |
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