Mac-Chem Products (India) Pvt. Ltd Boisar Jobs Vacancy | Regulatory Affairs API - Apply Now

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About Mac-Chem Products (India) Pvt. Ltd:

Mac-Chem is an NMM group company, we are a successful & diversified pharma group with a footprint in specialized segments like Oncology, General APIs and Bulk Sterile. We have manufacturing plants in four locations employing around 800 professionals. Mr B.K. Jain founded the group in 1985. Looming uncertainty of availability, as well as the quality of API, was putting tremendous pressure on the NMM group to keep up with the commitment of QCD (Quality, Cost and Delivery). The urgent need was to have our own API facility which will eliminate the uncertainties and help us to sustain our delivery commitments. Thus Mac-Chem was established in 2010. Mac-Chem has a CGMP-compliant manufacturing facility at Boisar, an industrial hub having more than 100 API manufacturing plants. It is located at a distance of around 100 km from the commercial capital of India, Mumbai.

Mac-Chem today has a National and Global footprint with a wide presence across the globe. Mac-Chem has carved a niche for itself in the exceedingly competitive and quality-conscious sphere of Active Pharmaceutical Ingredients (API) manufacturing with US-FDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP and ISO-certified facilities.

We seek to leverage our wide experience in International Marketing, our proficiency in scientific documentation and our ability to speedily secure regulatory approvals to make significant inroads in mark across the world. Today the name Mac-Chem is synonymous with quality. Mac-Chem’s entire work culture is fine-tuned to the philosophy of QCD (Quality, Cost and Delivery). Within a short span of time Mac-Chem has established itself as a trustworthy API partner in almost 40 countries worldwide. Our focus will continue to be on product & process innovation, faster turnaround time, optimizing cost, stringent quality standards and an aggressive customer-centric marketing approach. Customer and Employee satisfaction along with value addition for business partners will drive our growth plan.

About Mac-Chem Products (India) Pvt. Ltd Jobs Vacancy:

Position: Sr Manager.
Department: Regulatory Affairs – API.
Location: Boiser.
Experience:
- 8 to 10 Yrs of Experience in API Regulatory Filing for Stringent Regulatory Markets.
- Responsible for direct preparation and regulatory submissions to the agency including agency queries and post-approval changes.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.