General Manager – Pharmaceutical R&D

2 days ago

Ahmedabad, India Alpine Health Full time

Job Description: Head of Pharmaceutical R&D

Position Title: Head of Pharmaceutical Research & Development (R&D)

Location: Ahmedabad, Gujarat

Department: Research & Development


Position Overview:

The Head of Pharmaceutical R&D is responsible for leading and overseeing the formulation development activities within the pharmaceutical division. This senior leadership role involves developing finished formulation across different therapeutic segments and dosage forms, ensuring the successful progression of drug development programs, and managing cross-functional teams to bring new pharmaceutical products to market. The ideal candidate will have a strong background in pharmaceutical science, excellent strategic thinking, and experience in managing complex, multi-disciplinary projects from discovery through clinical development.


Key Responsibilities:


Strategic Leadership:

·       Develop and implement the overall R&D strategy aligned with the company’s business goals.

·       Drive the vision for new product development, portfolio management, and pipeline prioritization.

·       Securing intellectual property: Reviewing patents to protect the company's intellectual property

Project Oversight:

·       Oversee all phases of drug development, from RLD evaluation to BE study and commercialization.

·       Ensure timely progression of R&D programs, managing resources, timelines, and budgets effectively.

·       Provide detailed direction to formulation development team and ensure high standards of scientific rigor.

Team Management and Development:

·       Lead, mentor, and develop a team of F&D scientists, QA/ QC researchers, and project managers.

·       Oversee recruitment and talent development to build an R&D team.

Regulatory and Compliance Oversight:

·       Ensure compliance with all regulatory requirements, including FDA, EMA, and other regional regulatory bodies.

·       Work closely with regulatory affairs teams to support ANDA/MA submissions, BE Studies, and product approvals.

·       Ensure adherence to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and other industry standards.

External Collaborations and Partnerships:

·       Develop strategic partnerships with academic institutions, laboratories and other pharmaceutical companies to accelerate formulation development.

·       Negotiate and manage collaborations with external research organizations, contract research organizations (CROs), and consultants.

·       Work with manufacturing teams of CMO’s and CDMO’s for tech transfer of developed products and ensure smooth and controlled knowledge transfer of IP

·       Oversee product filling and commercial manufacturing activities and further correct issues faced during commercial manufacturing.

Risk Management:

·       Identify, assess, and mitigate risks associated with the development of pharmaceutical products.

·       Address scientific, technical, regulatory, and operational challenges in drug development.


Qualifications:

Education:

·       M. Pharm / M.Sc / PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Molecular Biology, or a related field.

Experience:

·       10+ years of experience in pharmaceutical Formulation development, with at least 5 years in a leadership role.

·       Proven track record of successfully bringing multiple generic drugs from RLD evaluation to filling and commercialization in worldwide markets.

·       Strong expertise in development processes, QA/QC and regulatory affairs.

·       Experience with a variety of therapeutic areas is preferred.

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