Biology Jobs at Apotex | Candidates Apply Now
Are you looking for Biology Jobs, Apotex Careers, or Executive Jobs in the pharmaceutical industry? Apotex is hiring for the position of Senior Executive – New Product Development in Mumbai. This exciting opportunity is ideal for candidates with a background in Biology, Pharmacy, Chemistry, Health Sciences, or related fields who want to contribute to regulatory affairs, product life-cycle management, and new product development in global pharmaceutical markets.
About Apotex
Apotex is a Canadian-based global health company focused on improving access to affordable, innovative medicines and health products worldwide. The company offers a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, Canada, Apotex operates globally with regional offices in the United States, Mexico, India, and other international markets. It is recognized as the largest Canadian-based pharmaceutical company and a trusted health partner for pharmaceutical licensing and product acquisitions across the Americas.
Key Responsibilities
- Manage product life-cycle activities for Apotex products in the US and Canada markets, including regulatory submissions and post-approval changes.
- Prepare, review, and maintain regulatory documents (NPD, PLCM, supplements, and deficiency responses) to ensure timely approvals and compliance.
- Coordinate with cross-functional teams and external partners to gather, compile, and submit regulatory information and documentation.
- Monitor regulatory compliance and documentation systems by maintaining databases, trackers, change controls, SOPs, and regulatory guidelines.
- Provide regulatory support and project coordination while ensuring adherence to company policies, quality standards, safety requirements, and organizational values.
Qualifications
- Graduate or Post Graduate degree in Chemistry, Biology, Pharmacy, Health Sciences, or similar.
- A project management qualification will be an additional advantage.
Experience
- Demonstrated knowledge of the generic new product development process and dossier compilation for key international markets such as Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore, and Malaysia.
- Demonstrated experience in influencing and coordinating complex regulatory activities.
- Experience working with cross-functional teams and stakeholders.
- Experience with regulatory submissions and product life-cycle management activities.
Skills Needed
- Strong knowledge of technical, quality compliance, and global regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Excellent understanding of Project Management principles and practices in a complex environment.
- Strong oral and written communication skills in English.
- Knowledge of MS Office Suite, especially:
- MS Word
- MS Excel
- MS Project (or other project management software)
- Ability to coordinate multiple regulatory projects and stakeholders effectively.
- Strong documentation, compliance, and regulatory assessment skills.
This opportunity through Apotex Careers is an excellent choice for candidates seeking Biology Jobs and Executive Jobs in the pharmaceutical sector. The Senior Executive – New Product Development role offers exposure to global regulatory affairs, product life-cycle management, and international pharmaceutical markets, making it a valuable career opportunity for qualified life science professionals.
