Trainee, Regulatory Affairs Labeling

6 months ago

Mumbai Maharashtra, India Apotex Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
Perform for all the labelling update and maintenance activities with respect to New Product Development Label creation and Product Life Cycle maintenance update for products in US and/or Canada Market. Interact with Point of contact for product allocated to understand any data related queries or data availability issues. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork. Interact on a peer level with ARPL colleagues and US/Canada affiliates for addressing Health Authorities requirement or queries. Maintain all the trackers for label to ensure the timely submission of the labels to health authority.

**Responsibilities**:

- Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US/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 change 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 Apotex 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.

**Job Requirements**:

- Education
- A Postgraduate/Graduate in pharmacy.
- Knowledge, Skills and Abilities
- Basic knowledge and/or understanding of regulatory requirements for filing labelling submissions in USFDA, Health Canada or ROW markets.
- Good interpersonal communication skills
- Demonstrate good writing skills and compilation of submission documents.
- Proofreading ability for reviewing technical documents required for dossier preparation
- Attention to detail to check packaging artwork material and specifications
- Ability to manage multiple projects/tasks and proactive participation in team building activities.
- Be accountable for assigned projects and provide prompt responses to queries from various stakeholders or regulatory authorities.
- Experience
- Must have theoretical understanding of labelling activities for any market - US or Canada

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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