Executive, Ra-arpl-nos Ar

6 months ago

Bengaluru Karnataka, 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**:
To compile, monitor submissions related to the Product Life Cycle Management (PLCM) of the assigned products for all regulatory markets (mainly for USA and Canada) including technology transfers (site transfers).

**Responsibilities**:

- To maintain the Product life cycle management activities (variations) of the company for regulated markets US, CA, EU, AU / NZ.
- Train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:

- Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
- Providing coaching, feedback and recognition.
- Continuously works towards process improvement/alignment to GTA processes/practices and activates more process oriented rather than individual oriented.
- Provides regulatory support to internal departments in Regulatory Authority Audits.
- Review of changes proposed by other departments/other sites/health agency’s requirement for approved products and relevant on-line change control forms.
- Relevant communication with counterparts and follow up with the respective departments required for compilation, submission and responding to respective query responses.
- Compile abd review of post approval submission package and query responses.
- Review and regulatory support to other functional departments for the APQRs / AQRS / Notifications (Mat2Mat & Shipment Under Quarantine)/ launch activities
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.

**Job Requirements**:

- Education
- M.Pharm/B.Pharm/M.Sc./B.Sc.
- Knowledge, Skills and Abilities
- Sound understanding regulatory affairs submissions related to technology transfers.
- Expertise in product life cycle management.
- People management skills.
- Ability to learn and adapt quickly.
- Ability to manage full workload across multiple projects.
- Excellent verbal and written communication skills
- Experience
- 6-8 years of experience in Regulatory Affairs activities which muct include 3 to 4 years of experience in team/people management.

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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