General Manager – Research & Development

Job Title: General Manager – Research & Development (R&D)

Industry Type: Pharmaceuticals / Biotechnology / Life Sciences

Role Category: Senior Management – R&D Operations

Department: Research & Development (Formulations / APIs / Biologics)

Employment Type: Full-Time, Permanent

Manufacturing Location: Ahmedabad

Experience Range:

15 – 22 Years of experience in pharmaceutical R&D, with strong exposure to global regulatory markets (US/EU), technology transfer, and team leadership.

Salary Range (INR):

₹45 – ₹70 Lakhs per annum (based on company scale, experience, and specialization)

Educational Qualification:

Mandatory: M.Pharm / M.Sc / M.Tech – Pharmaceutics, Chemistry, Pharmaceutical Sciences

Preferred: Ph.D. in Pharmaceutics / Chemistry / Drug Delivery

Additional certifications in regulatory affairs, QbD, or project management are advantageous

Role Overview:

The General Manager – R&D is responsible for leading and managing the R&D function for pharmaceutical product development, overseeing all scientific, regulatory, and operational aspects from conceptualization to submission and commercialization.

Key Responsibilities:

Lead formulation, analytical, or API development activities depending on product focus

Oversee the development of new generic and specialty products for regulated and semi-regulated markets

Supervise pre-formulation, lab-scale, scale-up, exhibit batch execution, and technology transfer

Ensure adherence to QbD principles, ICH guidelines, and global regulatory requirements

Manage preparation and review of technical documents: protocols, reports, CTD modules, ANDA/DMF dossiers

Facilitate coordination between R&D, RA, QA, Production, SCM, and BD for smooth project execution

Manage and mentor cross-functional scientific teams across formulation and analytical development

Drive innovation in formulation strategies, process optimization, and delivery systems

Review IP/patent landscapes and contribute to product differentiation strategies

Support site readiness for regulatory audits and due diligence exercises

Key Skills & Competencies:

Expertise in formulation or API development for regulated markets (US/EU/WHO)

Sound knowledge of global regulatory frameworks (USFDA, EMA, WHO-GMP, TGA)

Strong project management and cross-functional collaboration skills

Proficient in QbD, technology transfer, process validation, and regulatory documentation

Excellent analytical, problem-solving, and scientific decision-making skills

Familiarity with IPR, patent filing strategy, and freedom-to-operate assessments

Strong leadership qualities with ability to lead large scientific teams and manage multiple R&D projects