Published: March 9, 2018
- The Head of Regulatory Affairs will report to the COO, and will drive biosimilar commercialization initiative hands-on.
- This individual will be a key member of the Senior Management Team and must be a solutions driven leader that has been successful within a fast growing organization.
- Directs the development of regulatory strategy to deliver global registrations for the biologic products platform.
- Oversee the regulatory support for lifecycle management of biosimilar products globally.
- Represent the company in the interactions with global regulatory authorities and external business venues such as technical meetings, regulatory forums and with industry groups to leverage company positions and influence legislation and guidelines impacting the regulatory environment.
- Manage regulatory issues related to the global development of biosimilar products to compile high-quality global core dossiers, realize on-time approvals and support tactical promotion of marketed product.
- Ensure that regulatory development and lifecycle resources are focused on harmonized goals in line with the Program Management, Research & Development, Global Marketing and Corporate Development and Commercial for biologic products.
- 10+ years of management experience in the pharmaceutical biotech industry with emphasis on biologic development.
- Possess Regulatory Affairs experience for the commercialization of biosimilar products. The Leader needs to have biosimilar experience.
- Must have strong experience writing and submitting BLA’s & IND from scratch.
- Greater than five years management experience in regulatory affairs.
- Understands the key elements in the development process to facilitate regulatory report generation and issuance.
- Understands therapeutic uses of assigned products to facilitate decision-making.
- Understands global strategy and legislation.
- Direct experience working with global health authorities.
- Travelling to India will be required for this role.