Dr Reddy’s Laboratories Ltd. is seeking an experienced Analyst, Regulatory Affairs to join their team in Hyderabad, Telangana, India. As a leading multinational pharmaceutical company, Dr Reddy’s Laboratories is committed to accelerating access to affordable and innovative medicines.
About the Role
As an Analyst, Regulatory Affairs, you will play a critical role in ensuring compliance with regulatory requirements for pharmaceutical products. Your primary responsibilities will include:
Regulatory Document Preparation: Preparation and review of US ANDAs, 505(b)(2), EU, and Canada dossiers for parenteral products.
Deficiency Response: Preparation and review of deficiency responses, regulatory strategy notes, controlled correspondences, briefing books, labelling, artworks, and ScA meeting packages.
Collaboration: Coordination with internal stakeholders, including R&D, AR&D, SCM, FTO, and CTO, and external counterparts, such as CMO and CRO.
Issue Identification: Identifying open issues at product development, ANDA filing, and deficiency responses in consultation with the team lead/RA vertical head.
Commercial Launch Support: Providing support to the commercial launch team in reviewing progress and evaluating changes proposed for commercial batches.
Requirements
Education: M. Pharm, (link unavailable), or PhD in a relevant field.
Experience: 3-6 years of experience in regulatory affairs.
Skills:
Good communication skills: Written and oral communication skills.
Self-starter: Ability to work independently with a go-getter attitude.
Team player: Ability to work collaboratively with internal and external stakeholders.
Quick learner: Ability to prioritise information and adapt to changing regulatory requirements.
Good interpersonal skills: Ability to build and maintain relationships with internal and external stakeholders.
Why Choose Dr Reddy’s Laboratories?
Global Presence: Opportunity to work with a leading multinational pharmaceutical company with a presence in 66 countries.
Innovative Culture: Collaborative and dynamic work environment that encourages innovation and creativity.
Career Growth: Opportunities for professional growth and development in a rapidly evolving industry.
Diversity and Inclusion: Commitment to diversity and inclusion, with a focus on employing and nurturing a diverse workforce.
If you’re a passionate and motivated Regulatory Affairs professional ready for your next challenge, this is your chance to make an impact! 🚀
👉 Apply Now:
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