Regulatory Affairs Executive (USFDA) _Reputed Pharma Industry_Chennai Seven Consultancy

1.0 - 5.0 years

5 - 12 Lacs

chennai

Work from Office

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA Review of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

Posted 1 week ago

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Portfolio Analyst MSN Laboratories

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for conducting research and analysis to discover new product opportunities in Emerging Markets and providing valuable insights to support the Portfolio Selection Committee's decisions and Portfolio Strategy Planning, in alignment with MSN Labs" growth objectives. Your roles and responsibilities will include identifying new product/molecule opportunities across various therapies in the small molecules space based on medical and marketing feasibility. You will conduct thorough analysis of secondary market data to assess opportunities available across different therapies. Additionally, you will be required to perform preliminary IP landscaping of products concerning patents worldwide. Building and updating business cases for new products proposed for selection in the portfolio selection meeting will be a crucial part of your job. It will also be essential to constantly monitor market updates such as label expansions, competition entry, safety warnings, and quarterly sales for innovator brands and API suppliers for the selected products. Keeping track of competitor analysis to stay informed about market trends and identifying new entry channels for the company through in-licensing and other opportunities to drive business growth will be among your key responsibilities. Key mandatory skills for this role include a strong understanding of the IP landscape in the pharmaceutical industry across various markets, a good grasp of pharma regulatory aspects in the US, EU, and Emerging markets, familiarity with the Formulation selection process, including understanding medical uniqueness, commercial forecast, and fitment with MSN technical capabilities. You should also possess knowledge of forecasting, patient funneling, and pricing strategy, as well as experience with data platforms such as IQVIA, Corelli's, IPD analytics, and Global data. Effective communication and stakeholder management skills, strong analytical abilities with proficiency in Excel and PowerPoint are also essential. Qualifications required for this position are M. Pharm/M.Sc. Chemistry/MBA (preferably from Tier I Institute/University), and the desired work experience is 3 to 5 years in Portfolio, Strategy, and/or IPM.,

Posted 2 weeks ago

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Regulatory Affairs Executive GSS Pharma Pvt.ltd

1.0 - 3.0 years

3 - 5 Lacs

bengaluru, whitefield

Work from Office

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

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Regulatory Affairs Executive G S S Pharma

1.0 - 3.0 years

3 - 4 Lacs

Bengaluru

Work from Office

Role & responsibilities We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier Compilation, Pharma Regulatory, RA Executive

Posted 1 month ago

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Regulatory Affairs Executive GSS Pharma Pvt.ltd

1.0 - 3.0 years

3 - 5 Lacs

Bengaluru, Whitefield

Work from Office

Posted 2 months ago

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Executive - regulatory Era It Solution

6.0 - 10.0 years

5 - 8 Lacs

Faridabad

Work from Office

medical device / pharma - Exposure in QMS & implementation, Calibration/Validation & QA regulations (National & International). knowledge in medical devices responsible for ensuring process controls - corporate standards, prevent outflow of defects

Posted 3 months ago

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