Opportunity for M.Pharm or Ph.D as General Manager at Aculife Healthcare

Aculife Healthcare Pvt. Ltd Company is a part of $4 billion Nirma Group & it is one of world's largest Infusion & Injectable Company, having a State-of-the art manufacturing facility spread over 550 acres of land located near Ahmedabad, Gujarat. Aculife healthcare has global operation in more than 100 countries and it has subsidiaries in Brazil, Mexico & Vietnam. The manufacturing facility has 2 plants with FFS technology, 1 Glass injectable plant and a one dedicated R&D center equipped with advance technology and unmatched research team. Aculife has best in class quality infrastructure with the aim to assure high level of quality assurance through QBD & QAR. Aculife has developed strong footprint globally and have 1000 registrations to cater the demand of regulated and semi regulated market. Company's domestic business is driven by 4 divisions in therapeutic area of Critical care, Parenteral Infusion, Ophthalmic, Anesthesia & IV Fluids, at the same time we are the most preferred contract manufacturers for top Indian pharmaceutical companies.

Post : AGM/DGM/GM- RA

Team Size : 10+
Geographic Location : Ahmedabad (Corporate Office) Gujarat
Qualification : M. Pharm or Ph.D.
Experience : 15-20+ years' experience predominantly into injectable

Role & responsibilities :
• Devise, lead and implementation of global regulatory strategies taking into consideration the overall regulatory submission process as per country wise regulations
• Manage and monitor preparation, submission, and review of regulatory documentation in collaboration with cross functional expert and regulatory team lead.
• Managing Lifecycle of approved products based on submission and timely approved per relevant changes and timely renewal submission.
• Overseeing all aspects of regulatory processes, including product registrations, variations, renewals, and regulatory inspections. By ensuring that these processes are efficient, compliant, and aligned with business objectives.
• Facilitate regulatory support for Development of new product to commercialization level
• Guide and lead team for timely delivery of regulatory requirements.
Candidate Specification :
• Experience of 15-20+ years in pharmaceutical submission of injectable for Emerging market as well as regulated market
• Must be Proactive, Organized and effective communicator with the ability to build strong relationships within team as well as cross function
• Must demonstrate strong problem solving, negotiating and leadership skills.
• Fluency and command over English language and IT tools.
• Capability in managing people in a multiple reporting matrix structures
• Capability to promote team work and collaboration among different team functions