Ensures proper archiving of submission documentation and compliance with internal SOPs. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
This position provide active involvement and contribution in the Formulation R&D team in terms of technical and operational activities such as hands-on support to formulation development in parenteral formulations and interpretation of analytical results. The incumbent will perform other duties as assigned.
B.Pharm / M. Pharm with experience in R&D or a related role. Strong Analytical, Problem-solving, and Critical thinking skills., Excellent Communication and Coordination skills.
Regualtory Specialist II supports a team in the preparation and maintenance of complete and accurate regulatory documents in support of clinical research studies
Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry CDISC and regulatory compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
Keep pace with and align with the market developments. Needs to be aware of market dynamics, fluctuations, innovations etc. Understands scientifically how various product are placed in relation to competitor products and devise appropriate strategies to deal with them
Exercising excellent interpersonal communication skills to effectively and professionally liaise with the internal teams, healthcare professionals, and other key stakeholders