Pfizer
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Â Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Job Title: Assistant Manager – Regulatory Affairs (LEC)
Job Code: 1613812
Location : IND – Chennai Device – Hospira
Qualification/Experience:
Minimum – Postgraduate in Pharmacy or Science
- Minimum 4-6 years of CMC experience within a regulatory function. Knowledge of EU/US and international regulatory practices, policies.
- Knowledge of NDAs, MAAs, CTDs and other regulatory components.
- Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools document management systems, publishing tools and operating knowledge of databases.
- Good verbal and written communication skills.
- Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines.
- Team player and ability to work in a highly matrixed environment.
- Customer focus and attention to detail and accuracy is required.
- Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills.
Specific Job Responsibilities:
- Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
- Search Regulatory databases for Common Technical Document components or request them from appropriate market contacts, when not available.
- Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database Should be familiar with submission grouping practices. Interpret and apply global/regional CMC regulatory policies.
- Request documents from the sites/markets/center functions as needed.
- Request Ancillary documents from Ancillary documents team.
- Communicate with markets if clarification/prioritization is needed.
- Must be extremely organized as LEC projects can run across multiple products/markets.
- Author CTD sections , coordinate and manage the submission for global markets per their regulations.
- Follow up with all responsible disciplines to be able to meet timelines.
- Work with Regulatory and CMC Product Strategists in finalizing the entire request.
- Manage requests via submission planning tools.
- Support use of regulatory systems and managing documentation and information.
- Act as global CMC representative within cross-functional teams. Serve as the project lead for LEC projects within Pfizer Essential Health, providing regulatory assessments and developing regulatory strategies.
- Ensure compliance to Pfizer’s internal procedures and training SOPs.
- Remain knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
