Leben Life Sciences Pvt. Ltd. (LLS), a well-established pharmaceutical formulation company with over four decades of industry presence, has announced a new recruitment opportunity for experienced professionals in its Regulatory Affairs (Formulation) department. The vacancy is available at the company’s EU-GMP Approved Global Standard OSD & Semi-solids Formulation Manufacturing Facility located in Akola, Maharashtra.
Candidates with experience in analytical documentation, HPLC, method validation, and regulatory submissions are encouraged to apply.
Job Overview
Company Name: Leben Life Sciences Pvt. Ltd.
Position: Sr. Officer โ Analytical Documents Reviewer (Analyst)
Department: Regulatory Affairs (Formulation)
Job Location: Akola, Maharashtra
Industry: Pharmaceutical Formulation
Job Type: Full-Time
Eligibility Criteria
Applicants should possess any of the following qualifications:
- M.Sc. (Pharmaceutical Analysis, Chemistry or related discipline)
- M.Pharm
- B.Pharm
Experience Required:
- 2โ3 years of hands-on HPLC experience (Mandatory)
- Candidates with QC or ADL (Analytical Development Laboratory) background are eligible.
- Experience in analytical method validation, stability analysis, and documentation is preferred.
- Good understanding of ICH guidelines and regulatory documentation.
Roles & Responsibilities
Selected candidates will be responsible for:
- Preparing, reviewing, and compiling analytical sections of CTD/eCTD dossiers including Specifications, AMV, and CoA.
- Reviewing analytical method validation, method transfer, stability, and impurity data.
- Ensuring analytical compliance with ICH Q2, Q3, Q6, Q8, and Q9 guidelines.
- Coordinating with QC Analytical, ADL, R&D, and Stability teams.
- Performing gap assessments against target market regulatory requirements.
- Preparing analytical responses for regulatory authority queries.
- Supporting internal and external audits with analytical regulatory documentation.
- Tracking and communicating updates in analytical regulatory guidelines.
Required Skills
- Strong analytical documentation skills
- Hands-on HPLC expertise
- Knowledge of CTD/eCTD dossier preparation
- Understanding of ICH guidelines
- Regulatory documentation experience
- Excellent coordination and communication skills
Salary & Benefits
Expected Salary: โน5.0 LPA โ โน7.5 LPA (Approximate, based on qualification and experience.)
Benefits may include:
- Opportunity to work in a EU-GMP approved pharmaceutical manufacturing facility
- Professional career growth
- Exposure to global regulatory documentation
- Collaborative work environment
How to Apply
Interested candidates can send their updated resume to:
Email: career@lebenlifesciences.com
Contact Number: 7498035480
Candidates are advised to mention the position name “Sr. Officer โ Analytical Documents Reviewer (Analyst)” in the subject line of their email.
