Company Description
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We are a multinational pharmaceutical company specialized in the development, manufacturing, and licensing of high-quality generic medicines worldwide, operating primarily through a B2B business model.
We are currently seeking an experienced Regulatory Affairs Manager to join our Regulatory Affairs team. This role offers a unique opportunity to take ownership of global regulatory activities, work closely with Health Authorities and international partners, and contribute to the successful lifecycle management and launch of products across multiple regions.
Specific Job Responsibilities:
· Manage and oversee the lifecycle of marketing authorization applications (MAAs), including national procedures, DCPs, MRPs, and RUPs, as well as post-approval activities such as variations (Type IA/IB/II) and renewal applications submitted by Intas affiliates and global customers.
· Act as the primary point of contact with Health Authorities, ensuring effective communication and timely responses to regulatory queries.
· Liaise with suppliers and clients to define and align dossier requirements in Eurasian countries.
· Coordinate and execute national phase activities with National Competent Authorities.
· Prepare, review, and maintain high-quality regulatory compliance documentation in accordance with applicable guidelines.
· Provide regulatory and technical support to the Business Development department.
· Collaborate internally with cross-functional stakeholders to coordinate activities and ensure successful and timely product launches.
· Represent the company and the Regulatory Affairs department in interactions with clients, partners, and external service providers.
· Manage change control and change request processes in accordance with quality and regulatory requirements.
· Coordinate discussions and activities related to Quality Assurance (QA) and SDEA.
· Monitor and maintain up-to-date knowledge of global regulatory legislation, guidelines, and industry trends. xsgfvud
Core Competencies
· Action oriented
· Time management
· Customer Focus
· Peer Relationship
· Problem solving
Relevant Functional/ Technical Skills or Industry Experience
- Minimum 5-year experience in pharmaceutical industry, Generic industry preferred
- Fluent English, written and spoken.
- Microsoft office package
- Able to prioritize work load
- Good organizational skills
Relevant Professional / Educational Background:
- University degree in scientific discipline (Pharmacy, Biology, Chemistry, etc)
- MSc or post degree specialization in Pharmaceutical industry and/or regulatory affairs is valued
- Knowledge of Quality Assurance and Phamarcovigilance