Home Regulatory Affairs Manager/Sr Executive | Regulatory Affairs EM | Sun Pharmaceuticals | Vadodara

Manager/Sr Executive | Regulatory Affairs EM | Sun Pharmaceuticals | Vadodara

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Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by over 40 manufacturing facilities spread across six continents and R&D centers across the globe. Innovation is at the core of the Sun.

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 We have nearly 2000 scientists working in six research centers across India, Israel, and the USA who have a passion for innovation and longing to provide better healthcare to humanity at large. Our multi-cultural workforce, comprising over 30,000 employees from 50 nationalities, is our biggest strength. We recognize our employee’s passion for growth and empower them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.

Position: Manager/Sr Executive Regulatory Affairs – Emerging Markets

Location: Vadodara, Gujarat, India

Job Description: 

1. Understanding and knowledge of regulatory guidance for new dossier submission and post-approval variation on key emerging markets like Brazil & rest Latam countries, South Africa, Russia, and ASEAN region
2. Planning and preparation of registration dossier in conventional/country-specific format and CTD/eCTD/ACTD.
3. Coordination with different stakeholders of various departments i.e. FDD, ADD, CAL, packaging, PMO, plant, and overseas regulatory counterpart.
4. Good understanding and potential on life cycle management activities i.e. renewal dossiers and post-approval variation.
5. Handling and preparation of draft response against queries raised by regulatory agencies within the stipulated timeline.
6. Candidate should have good communication and interpersonal skills.
7. A good understanding of analytical validation including a resolution on analytical issues should be preferred.

Qualification: M.Pharma

Experience: 6-9 Years

Salary: Negotiable

Contact Details:

hrd@sunpharma.com, vignesh.iyer@sunpharma.com

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