Sr. Manager-FRD (Solid Oral + Complex Injectable), Navi Mumbai

Best Fit Recruitment Rider; Navi Mumbai; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

BEST-FIT Recruitment Riders is seeking a Senior FRD Manager to lead formulation development for solid oral and sterile injectable products targeting Russia and CIS markets. The role requires 10–15 years in FRD with strong DoE/QbD and regulatory expertise.

The incumbent will drive regulatory strategy, oversee tech transfer to manufacturing, and coordinate with ARD/QA/RA to ensure compliant filings. Navi Mumbai location, global project exposure.

Qualifications

• M.Pharm or Ph.D with 10–15 years in Formulation Research & Development in Pharmaceutical R&D.
• Strong experience in OSD formulation development & Sterile injectable development.
• Experience with Russian / CIS markets preferred.
• Proven track record of regulatory approvals and product launches.
• Knowledge of DoE and QbD approaches.
• Regulatory documentation and compliance expertise.

Responsibilities

• Lead development of OSD and injectable formulations for Russia and CIS markets.
• Ensure products comply with EAEU/Russian regulatory requirements.
• Prepare documentation for product registration in Russia, CIS markets.
• Coordinate with ARD, QA, QA, RA, Production and Engineering for smooth tech transfer.
• Plan stability studies and review data per ICH guidelines.
• Manage research timelines and allocate projects.
• Ensure milestones and product development goals are met.
• Oversee technology transfer from R&D to manufacturing.
• Inspect and optimize formulation development equipment and processes.
• Support regulatory audits and inspections with robust technical files.
• Collaborate on DoE studies and QbD-based design spaces.

Skills

Formulation R&D

OSD formulation development

Sterile injectable development

DoE

QbD

cGMP/GLP/ICH

Regulatory approvals

Project management

Education

M.Pharm / Ph.D

Job description

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in

We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client.

Please see the following position summary:

1. Client: Growing Russia based Pharma
2. Position: Manager / Sr. Manager - FRD
3. Markets: Russia & CIS countries
4. Products: Solid Oral & Injectable
5. Reporting to: Technical Director (India) + Promotor (Russia)
6. Job Location: Mahape, Navi Mumbai

Role Overview

Responsible for the development, optimization, and scale-up of pharmaceutical formulations such as tablets, capsules (OSD) and sterile injectable products for Russia and CIS regulatory markets. The role includes product development, regulatory support, technology transfer, and commercialization support aligned with the regulatory requirements of Russia, Kazakhstan, Belarus, Uzbekistan, and other CIS countries.

Role & responsibilities

• Lead formulation development of OSD & Injectable for Russia & CIS markets.
• Develop pharmaceutical products compliant with EAEU / Russian regulatory requirements.
• Prepare documentation for product registration in: Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan, Uzbekistan and other CIS markets.
• Ensure products meet Russian regulatory, Eurasian Economic Union (EAEU) and ICH guidelines.
• Conduct Pre-Formulation & Compatibility Studies.
• Perform laboratory trials and evaluate formulation feasibility.
• Design experiments to achieve bioequivalence with reference products
• Process Development & Scale-Up
• Manage technology transfer from R&D to manufacturing plants.
• Plan and review stability studies according to ICH stability guidelines.
• Allocate research projects and monitor development timelines.
• Ensure project milestones and product development goals are achieved
• Prepare and review technical documentation required for product registration in Russia and CIS markets.
• Work closely with ARD, QA, QC, RA, Production & Engineering.
• Operate and maintain formulation development equipment such as: High-shear mixers, Fluid bed processors, Lyophilizers, Homogenizers, Filtration systems etc.

Preferred candidate profile

• M.Pharm / Ph.D with 10 to 15 years experience in Formulation Research & Development in Pharmaceutical R&D.
• Strong experience in OSD formulation development & Sterile injectable development
• Expertise in product development for Russian / CIS markets would be preferred first.
• Proven track record of successful product launches and regulatory approvals.
• Knowledge of Design of Experiments (DoE) and Quality by Design (QbD) approaches.
• Ability to plan and manage multiple product development projects simultaneously.
• Understanding of cGMP, GLP, ICH guidelines.
• Expertise in solving formulation challenges related to bioavailability, stability, and manufacturability.
• Ability to interpret analytical data, stability data, and dissolution profiles
• Experience in technology transfer from R&D to commercial manufacturing.
• Strong documentation and regulatory knowledge.
• Exposure to international audits and regulatory inspections.
• Ability to work in a fast-paced international pharmaceutical environment.

Key Competencies

• Analytical and problem-solving ability
• Scientific research and experimental design
• Project management
• Documentation and regulatory compliance
• Cross-functional teamwork