Assistant Manager - New Product Development

Apotex Inc.; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Apotex Inc. is a Canadian-based global health company seeking a Regulatory Affairs professional to lead the preparation and submission of regulatory dossiers for US and Canada. You will maintain documentation, provide guidance to cross-functional teams, and ensure timely responses to regulatory inquiries.

The role emphasizes collaboration, accuracy, and adherence to global regulatory policies. The ideal candidate will have 10+ years of experience in regulatory affairs for US/Canada markets,

Qualifications

• Graduate or postgraduate in Chemistry, Biology, Pharmacy, or Health Sciences.
• Understanding of global regulatory requirements for US and Canada.
• Excellent communication and interpersonal skills.
• Experience coordinating regulatory activities with cross-functional teams.

Responsibilities

• Prepare and review quality regulatory submissions for US and Canada to ensure timely approvals.
• Maintain regulatory documents and trackers to support compliance.
• Provide regulatory guidance to the team for project delivery and submissions.
• Coordinate with third-party manufacturers/partners for documentation for submissions.
• Interact with other departments to resolve regulatory issues.

Skills

Regulatory affairs

Project management

Communication skills

MS Office

English proficiency

Education

Chemistry/Biology/Pharmacy degree

Project Management (advantage)

Tools

MS Office

MS Word

MS Excel

MS Project

Job description

Job Description:

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .

Job Summary

• Responsible for the new submission of Apotex and Co-partner's products in US and Canada markets.
• Preparation of submission and approval notifications for applications submitted to Regulatory agencies (US and Canada)
• 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.

Job Responsibilities

• Responsible for the preparation and review of quality regulatory NPD submissions for various regulatory markets (US and Canada) to ensure timely approval.
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
• Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
• 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.
• Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
• Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
• Co-ordinate with third party manufacturers/partners for document requirement 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 new submissions and query responses to meet 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/Partner to discuss and provide solutions to regulatory issues and/or problems.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage and Innovation
• 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:
• A Graduate/Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar. Project Management would be additional advantage.
• Knowledge, Skills and Abilities:
• Demonstrated knowledge of the generic new product development process/requirements and compilation of dossier for key regulated markets such as US and Canada.
• Must possess knowledge of the technical, quality compliance, and global regulatory requirements.
• Excellent communication, presentation, and interpersonal skills.
• Demonstrated experience in influencing & coordinating the complex regulatory activities and interaction with cross-functional teams & stakeholders.
• Excellent understanding of Project Management principles and practice in a complex environment.
• Excellent oral/written communication in English.
• Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software).
• Experience: Core Regulatory Affairs
• Candidate should have minimum 10 years of experience in US and Canada market.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.