Executive- Labelling, Regulatory Affairs

5 months ago

Mumbai Maharashtra, India Apotex Research Private Limited 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 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 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**:

- Responsible for coordination & preparation of regulatory submissions and strategies.
- Prepare and submit all the supporting documents for labelling submissions as per the type of submission for 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.)
- Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada market.
- Develop & maintain regulatory knowledge of Canada regulations.
- Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product approvals.
- 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 labelling requirements and plan the submission based on priority.
- 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.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- M Pharmacy, B Pharmacy or Equivalent Degree
- 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
- Collaborate with team members.
- Other Techniques: Plant tissue culture (seed germination, Direct-Indirect Organogenesis, Micropropagation), Biochemical assays (Protein estimation, Sugar estimation).
- Self motivated, taking responsibility and taking initiative.
- Experience:

- Must have labelling experience in any market - US, Canada, Europe or ROW.

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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