Founder at TechnoScience
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Regulatory Affairs - Labelling (1-5 yrs)
- Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada market.
- Prepare and submit all the supporting documents for labelling submissions as per the type of submission for US and Canada Market.
- Co-ordinate with POC/ Vendor for Artwork creation and update.
- Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.)
- Perform ESG submissions and maintain the acknowledgments.
- Author the responses and be a decision maker for the changes applicability in the labels
- Define the priority of the labeling requirements and plan the submission based on priority.
- May provide input and feedback to departmental process improvement strategy discussions
- Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
- Liaises regularly and develops strong working relationship with external partners and international affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
- Maintains user-level knowledge of labelling software- s
- Interacts with other internal departments when necessary.
- Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance knowledge.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Courage, Collaboration, Perseverance and Passion demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
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