Pfizer
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. 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: Senior Manager- Regulatory Affairs (LEC)
Job Description:
- Manage the day to day work activities of the team along with the regulatory activities associated with projects assigned to the team and self.
- Responsible for timely readiness and submission of the supplements / variations related to Legal Entity Changes (LEC) and other deliverables of the team.
- Remain knowledgeable 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.
- Provide review support and guidance to the team members on the following activities:
- Change control evaluation for completeness, accuracy and adequacy of supporting documents as well as change controls initiation, when needed.
- Regulatory databases searches for Common Technical Document components or sourcing through appropriate market contacts, when not available.
- Documents requests from the sites/markets/center functions as needed.
- Ancillary documents requests from Ancillary documents team.
- Communication with markets if clarification/prioritization is needed.
- Authoring CTD sections, coordinating and managing the submission for global markets per their regulations.
- Must be extremely organized as LEC projects can run across multiple products/markets.
- Follow up with all responsible disciplines to be able to meet timelines.
- Work with LEC Team members, 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 all the LEC projects within Pfizer Essential Health, providing regulatory assessments and developing regulatory strategies.
- Ensure compliance to Pfizer’s internal procedures and training SOPs of the team and self.
- Remain knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
Qualifications:
To function as a team lead working with Regulatory Strategists handling supplement/variation submission for Legal Entity name Change globally , working in collaboration with the regional regulatory leads and global product leads.
Qualification/Experience
· Minimum – Postgraduate in Pharmacy or Science
- Minimum 7-10 years of CMC experience within a regulatory function.
- Minimum 2-3 years of people management experience is preferable. Able to mentor and train the team to meet the deliverables.
- Knowledge of NDAs/ANDAs, 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.
- Ability to handle multiple projects with good prioritization skills.
- Willingness to work flexible hours.
