Location: Thane, Maharashtra, India
Division: Pharmaceuticals
Reference Code: 820385
Company: Bayer
Job Description:
- Responsible for all Regulatory Affairs activities concerning Radiology drug products in India (IN), Nepal (NP), and Sri Lanka (LK).
- Provide effective functional leadership and governance into planning, development, and execution of regulatory strategies.
- Prioritize and align regulatory work with business plans and strategies through cross-functional collaboration.
- Manage regulatory activities with relevant Health Authorities and government bodies regarding Radiology contrast media marketing authorization/permission/notification.
- Balance business objectives and priorities within assigned portfolio and geography, allocating resources accordingly.
- Ensure best regulatory planning and preparation for new chemical entities, new indications, and line extensions.
- Maintain compliance with all relevant regulatory, corporate, and legal policies throughout the product lifecycle.
- Partner with relevant stakeholders to assist in achieving optimal company outcomes, including global regulatory affairs.
- Support APAC contrast media regulatory development and compliance activities.
- Ensure local maintenance of required licenses and compliant regulatory practices.
Functional Excellence Responsibilities:
- Lead operational activities within the team to ensure professional regulatory checks and timely delivery of documentation.
- Identify and implement efficiency and productivity goals for the integrated RA organization.
- Collaborate with regional and global regulatory to manage resources and meet regulatory needs.
- Ensure preparation of application files for products and clinical trials in accordance with local regulations.
- Work closely with Pharmacovigilance (PV) for PSUR and AE reporting.
- Provide regulatory expert input for quality management, product complaints, and recall processes.
- Support product registration and maintenance for export products and local/regional tenders.
- Handle test license applications for the import of materials for testing in India.
Candidate Profile:
- Master’s degree in Life Sciences or equivalent scientific degree.
- Minimum of 5-7 years of pharmaceutical industry experience in regulatory affairs, with at least 2 years in a leadership/technical specialist role.
- Proven experience in health authority interactions, managing projects, and resources.
- Strong pharmaceutical product knowledge and hands-on experience across various applications.
- Excellent interpersonal and communication skills, both orally and in writing.
- Analytical capability to evaluate complex situations and proactively identify potential issues.
- Fluent in English and local language.
- Ability to organize, prioritize, and direct diverse activities in a changing environment under time pressure.
Application: Interested candidates should apply with the reference code 820385.
About Bayer: Bayer is committed to advancing Science and Social Innovation for global health and hunger solutions, supporting both fundamental research and social innovators to bring lasting change to communities.
