Regulatory Affairs Officer/ Executive

5 days ago

Pune, India Imaec Medntek Full time

Our highly skilled workforce, with their unwavering commitment to excellence, will be the critical pillar for IMAEC MEDNTEK's success story. We will achieve our shared goals and organizational objectives by strategically focusing on attracting, retaining and developing the correct talent mix with diversity in relation to gender, age, expertise and geographical heterogeneity. At IMAEC MEDNTEK we provide an opportunity to our employees to share across their innovative ideas and views. We ensure their talent enhancement and career growth with our core development strategy. We are providing an environment for our employees to feel connected at all levels of their personal and social developmental stages. We are here building trust and believing in our people/stakeholders.

**Roles & Responsibilities for Regulatory Affairs Officer/Executive : -**
- Registration of products and manufacturing site with the regulatory authorities of various countries.
- Understanding, Searching, Preparation, compilation and submission of Registration/ Site Registration documents for different countries
- Understanding, Searching, Preparation, compilation and submission of Dossiers, Technical Files & CTDs/ACTDs/e:CTDs documents for different countries.
- Interacting and conducting meetings with regulatory POCs from the distributors of the exporting countries inline to ensure regulatory requirements and compliance.
- Identifying the guidelines and keeping up to date/record with the global regulatory requirements.
- Coordinating with cross-functional teams for the regulatory activities.
- Ensuring timely completion of regulatory activities and submission of regulatory documents.
- Country wise/Client wise maintenance of all regulatory record
- Any suitable activity assigned by Reporting Manager, CEO & Management.
- Education & Experience requirement - 2 Open Positions.

1 No with **MSc (Inorganic chemistry)** and 1 No with **M Pharm**.
- Fresher or preferably with 1 years of industrial experience in pharma field with Regulatory or quality function.

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