Job Description

Experience: 15 + years

Location: Kolkata

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 and approval of all applications
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil

Country regulatory and quality standards

• Plan, undertake and oversee product 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
• Review and report overall quality status to the management team
• Project management of development of new generic products

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 working with generics is an advantage
• Experience in pharmacovigilance is an advantage