Lyrus Life Science – Hiring for Regulatory Affairs

Lyrus Life Science was incorporated with a specific objective of providing value added products across therapies. The leadership team is focused and brings more than 300 years of combined experience within pharmaceutical formulation development, manufacturing and marketing across globe with a reputation of remaining a trusted partner for major global MNCs like Pfizer, Novartis, Sanofi-Aventis, and GSK. Lyrus is now a full spectrum Contract Research & Development Organization. Well equipped with various ultramodern equipment and technologies, Lyrus is capable of offering services across the value chain.

 

We’re Hiring! | Senior Officer / Executive – Regulatory Affairs
At Lyrus, we are driven by research, technology, and a passion for transforming healthcare. As a global specialty pharma CDMO company, we pride ourselves on innovative drug delivery solutions backed by world-class R&D, cGMP manufacturing, and a leadership team carrying 300+ years of collective expertise.
As we continue to grow, we’re expanding our Regulatory Affairs team.
If you are someone who thrives in compliance, dossier excellence, and global regulatory strategy — this is your opportunity! 👇

🔍 Who We’re Looking For

• Qualification: B.Pharm / M.Pharm
• Experience: 3–4+ years in Regulatory Affairs
• Proven track record in dossier preparation for tablets, capsules, or liquid dosage forms (Modules 1–3)
• Exposure to dossier submissions in Europe, GCC, South Africa, or ROW markets is a strong plus

Mandatory technical skill and experience

At least 4 years of experience in Regulatory Affairs Hands on dossier handling (M1 to M5) in Europe & Australia region for OSD Dossier preparation in other regions like, US, South Africa, GCC and ROW is considered as add on experience e-CTD software management

Other skills

Good verbal and written communication skills Should be a team player Must be able to meet deadline with a positive attitude and atmosphere

Key Responsibilities

Coordinate with the cross functional team members for the documents Hands on review of technical documents like specifications, AMV, CDP, stability reports  Prepare and review product labels for Europe and other markets Preparation and compilation of IND dossier for submission to EU, TGA and semi regulated market.  Preparation of variation sequence  Respond to the queries within assigned timelines. Maintain regulatory database and documentation. Develop and manage regulatory tracking systems to monitor submission timelines and approvals.

 

 

How to Apply:

• link to apply and upload your CV – https://forms.gle/XvsZvXmPbUxGYydg6
• If you’re detail-oriented, globally engaged, and passionate about regulatory science, we’d love to meet you! See the full job description here: https://lnkd.in/g-_qmABK
• Apply via the official application form link below:
  https://lnkd.in/gvT-zhc2

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