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Principal Scientist | Regulatory Affairs | Hyderabad, Mumbai


Harman Finochem Limited is a leading India-based Pharmaceutical Company that specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APIs) of which 10 are Essential Drugs as per the WHO Model List.

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We deliver top quality products to more than 35 countries across the globe. Visit to know more about us http://harmanfinochem.com/about-us/

Position: Principal Scientist – Regulatory Affairs

Location: Hyderabad, Telangana/Mumbai, Maharashtra

Job Description:

The Principal scientist (Regulatory Affairs ) is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.

The position reports to Senior VP R&D.

Responsibilities and main tasks:

  • Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
  • Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
  • Provide expert regulatory input to in-licensing evaluations and due diligence activities
  • Provide advice about regulations to manufacturers/scientists
  • Coordinate successful submissions across the globe and approval of all applications
  • Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfill European/US regulatory and quality standards
  • Collaborate on providing regulatory insights to R&D trials and regulatory inspections
  • Keep up-to-date with changes in regulatory legislation and guidelines
  • Write comprehensible, user-friendly, clear product information leaflets and labels
  • Liaise and negotiate with regulatory authorities
  • Develop and establish policies and standards that convey the best practices in the company
  • Regulatory Project management of development of new generic products
  • Use a variety of specialist computer applications
  • Deep experience from the pharmaceutical industry from a regulatory affairs perspective
  • Knowledge of European/US pharmaceutical legislation, relevant guidelines, procedures and requirements
  • Fluent in oral and written English
  • IT skills –well versed in DMS/SAP/ Office 365/ Publishing ECTD/ACTD/

Desired Skills/Experience:

  • Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
  • Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
  • Strong initiation and organizational skills
  • Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
  • Strong analytical skill and technical/ scientific competence
  • Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
  • Team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude
  • Proactive, quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion
  • Experience from generics across the globe
  • Experience in pharmacovigilance is an advantage

Qualification: MS/M.Sc, M.Pharma

Experience: 22-27 Years

Salary: Negotiable

Contact Details:

Ms. Deepika Khosla

deepikak@harmanfinochem.com, careers@harmanfinochem.com

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