Regulatory Affairs Job at Apotex | MSc Organic Chemistry Graduates Apply Now
Are you looking for a rewarding Regulatory Affairs job, exciting opportunities under Apotex careers, or high-quality Chemistry jobs in Mumbai? Apotex, a leading global pharmaceutical company, is hiring an Executive in Global Regulatory Affairs at its Mumbai location. This role offers a dynamic environment where experienced professionals can contribute to regulatory submissions, product life-cycle management, and compliance across international markets.
About Apotex Inc.
Apotex is a leading global pharmaceutical organization recognized for its commitment to innovation, affordability, and access to healthcare. With a strong presence in India, Apotex offers diverse opportunities in Regulatory Affairs, Chemistry, Pharmaceuticals, and Life Sciences. As part of Apotex careers, employees experience a collaborative work culture, international exposure, and professional development in a world-class research and regulatory environment.
Job Details
- Job Post: Executive, Global Regulatory Affairs
- Education: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.
- Knowledge, Skills, and Abilities:
The candidate should know the Post-approval change submission requirement and compilation of variation packages for the US/CAN/EU/AUS-NZ/ROW markets. - Experience: Candidate should have at least 3 years of experience in the US/CAN/EU/AUS-NZ/and ROW markets.
Job Summary
Responsible for the product life-cycle management of Apotex products (Toronto) in identified
markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes, and procedures. Leading and/or coordinating regulatory affairs projects, as assigned. Preparation of submission and approval notifications for applications submitted to Regulatory agencies. This opening is an excellent opportunity for professionals seeking Regulatory Affairs jobs or Chemistry jobs in Mumbai within a respected global organization.Job Responsibilities
- Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
- Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
- Accountable for assessment, coordination, and compilation of deficiency responses in a timely manner.
- Works with other functional areas to resolve issues related to information for regulatory submissions.
- Evaluate, prepare, and review post-approval supplements to manage the regulatory product life-cycle as applicable.
- Assessment of change control documents. Review of change control forms and provide an accurate assessment for the change being assessed (as applicable and assigned).
- Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet, etc.) and ensure accuracy of information.
- Coordinate with third-party manufacturers for document requirements for regulatory submissions.
- Act as a back-up for team members and support as & when required.
- Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet the agreed timeline.
- Interpret and ensure compliance with SOPs, RA policies & procedures, and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
- Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
- Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
- 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.
