Executive/Senior Executive - Regulatory Affairs (API)

Company Profile:

Amarant Lifesciences provides support in the Lifesciences Industry, including the API, pharmaceutical and Biotechnology industry in various domains such as GxP and Compliance, pharmacovigilance, scientific consulting, regulatory affairs and liaison with regulatory authorities, gap analysis of documents and data, designing pathways for studies, selection of CROs, Monitoring of pre-clinical and clinical studies, Technology transfers & licensing for various markets.

The experienced team members with more than 20 years of experience each support the clients at any stage of their business. The Amarant team has extensive experience in various regulatory environments such as India, the US, Europe, etc., and brings this value to the table when assisting our clients with their strategic and operational requirements.

The team comprises Pharma and Biotech experts from Regulatory, Pre-clinical, Clinical, Pharmacovigilance, Business Development, Manufacturing, GxP & Project Management domains who have previously held senior roles within the industry and can advise on the strategy, support implementation, and assist in operational excellence in various areas.

Amarant also delivers customized training on various aspects such as regulatory, GMP, compliance, toxicology, and clinical studies, etc.

At Amarant, you have a great opportunity to contribute as a part of the global regulatory Team as well as learn new requirements and grow both horizontally and vertically.

Role Description

You will be responsible for preparing and reviewing various eCTD sections of the regulatory submissions (ASMF/CEPs) and data packages for European markets.

Responsibilities:

1. To coordinate with the concerned departments for arranging the required technical data for the preparation of ASMF/CEP & technical packages
2. To review quality and manufacturing data for APIs in terms of their regulatory adequacy as per respective regulatory requirements
3. To prepare various ASMF/CEP dossier sections and technical packages
4. To review DMFs of the intermediates and APIs as a part of vendor selection 
5. To assist preparation of amendments and deficiency responses
6. To prepare a technical data package for submission of post-approval variations
7. To support in writing responses to regulatory deficiencies based on the data made available by the concerned cross-functional departments
8. To maintain a repository of API dossiers and of regulatory commitments and make them available timely manner wherever required

Experience, Education & Skillset:

1. Education: Minimum Science Master's degree (e.g., Pharmacy, Chemistry, Biochemistry) or equivalent
2. 2-5 years of regulatory experience in the API regulatory submissions (ASMF/CEP)
3. Self-starting/motivated and able to work within teams
4. The ability to grasp new concepts quickly and to assimilate & evaluate scientific data
5. Written and oral communication skills
6. IT skills (MS Word/Excel) - particularly for writing dossier sections in MS Word
7. Strong work ethics and professionalism
8. API Regulatory submissions (ASMF/CEP applications/Technical data packages)
9. European Medicines Agency (EMA) & MHRA (UK) for CTD, DMF/CEP