24/08 Cheryl Lopes
Founder at TechnoScience

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Regulatory Affairs - Labelling (1-5 yrs)

Mumbai Job Code: 19110

Job Responsibility

- 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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