Asst Manager / Manager – Project Management (Regulated / Emerging Markets)

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

Position :

Asst Manager / Manager – Project Management (Regulated / Emerging Markets)

Job Summary The role is responsible for planning, coordinating, and driving formulation R&D projects for products intended for regulated and emerging markets. The incumbent will ensure timely execution of formulation development activities, compliance with regulatory and quality requirements, and effective cross-functional coordination from development through scale-up and technology transfer.

Key Responsibilities:

Project Planning & Execution Manage end-to-end formulation R&D projects from concept to exhibit / validation batch and technology transfer. Develop and track detailed project plans, timelines, and milestones. Ensure timely completion of formulation development, optimization, and scale-up activities. Formulation Development Coordination Track availability of APIs, excipients, reference standards, and development materials. Align formulation strategy with target market (regulated vs emerging) requirements. Cross-Functional Coordination Act as the central coordination point between Formulation R&D, Analytical R&D, Regulatory Affairs, Quality Assurance, Production, Purchase, and Supply Chain. Facilitate stage-gate, development review, and project governance meetings. Prepare MOMs and ensure timely closure of action items. Regulatory & Quality Compliance Ensure formulation development activities comply with cGMP, data integrity, and internal quality systems. Track regulatory deliverables including development reports, stability studies, and submission readiness. Support regulatory filing timelines for regulated and emerging markets. Material, Vendor & Cost Management Coordinate with Purchase for PR/PO initiation, vendor qualification, and material availability. Support vendor qualification activities. Risk Management & Continuous Improvement Identify technical, regulatory, and supply risks related to formulation development. Drive mitigation plans to avoid project delays. Support continuous improvement initiatives to optimize formulation R&D timelines.

Required Skills & Qualifications

Master’s degree in Pharmacy, Life Sciences, Chemistry, or related field 10-12years of project management or relevant experience in regulated/emerging market in pharma industry. Strong knowledge of regulatory pathways, GMP / GxP, and submission processes. Proven ability to manage multiple projects simultaneously. Excellent communication, leadership, and stakeholder-management skills. Proficiency in project management tools (MS Project, Word, Excel, etc.) is desirable.

Competencies Strong analytical and problem-solving skills Detail-oriented with high organizational capability Ability to work in cross-functional and multicultural environments Proactive, self-driven, and capable of managing ambiguity Effective presenter and communicator

Reporting Line Reports to Head – Project Management