Company Overview

Shilpa Medicare Limited (SML) is a global brand in manufacturing and supplying affordable Active Pharmaceutical Ingredients (API) and Formulations and biologicals in different regulated markets. With a history dating back to 1987, SML has grown to become a trusted name in the pharmaceutical industry. We are committed to providing quality healthcare solutions to patients around the world.

Job Overview

We are seeking a highly experienced and knowledgeable individual to join our team as the Head Of Regulatory Affairs. This role will be responsible for leading and managing all regulatory activities for our company. The successful candidate will have a strong background in regulatory affairs within the pharmaceutical industry, with expertise in formulations, 505(b)2, ANDA, Oncology, injectables, OSD, and other relevant areas. The role is based in Hyderabad, Telangana, India and is a full-time position.

Qualifications and Skills

• Minimum of 20 years of experience in regulatory affairs within the pharmaceutical industry
• Strong knowledge and understanding of regulatory requirements and guidelines
• Experience with formulations, 505(b)2, ANDA, Oncology, injectables, OSD, and other relevant areas
• Excellent communication and interpersonal skills
• Ability to effectively lead and manage a team
• Detail-oriented with strong analytical and problem-solving abilities
• Proven track record of successful regulatory submissions and approvals
• Ability to adapt to changing regulatory environments
• Experience in regulatory affairs in global markets is a plus

Roles and Responsibilities

• Lead and manage all regulatory activities for the company
• Ensure compliance with local and international regulatory requirements
• Develop and maintain strong relationships with regulatory authorities
• Keep up-to-date with regulatory developments and communicate changes to relevant stakeholders
• Provide guidance and support to cross-functional teams on regulatory matters
• Review and approve regulatory documents, including submissions and labeling
• Collaborate with internal and external stakeholders to ensure timely approval of new products
• Conduct regulatory assessments to identify risks and mitigation strategies
• Manage regulatory inspections and audits
• Stay abreast of industry best practices and proactively implement improvements