Pfizer B Pharma Vacancy – Regulatory Associate Post
Dont forget to check out possible interview questions for this job below
Pfizer B Pharma Vacancy – Regulatory Associate Post Pharma job opening 2023, Pharma job opening 2023, job opening 2033, Intrested and eligible candidates may check out all the details
Job Title: Associate II – Regulatory Change Manager
Location: India – Chennai
- Bachelor’s Degree in pharmacy, Biotechnology or Science background
- Demonstrated 2-3 years of experience.
- Relevant experience in electronic submissions build within the Pharmaceutical Industry
- Demonstrated coordination of activities in a highly regulated environment
- Demonstrated experience working in a challenging customer service environment.
- Knowledge of the drug development process
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
- Good knowledge of English, spoken and written
Experience in project management
Master’s degree in pharmacy, Biotechnology or Science background
How You Will Achieve It
Partnering with internal and external partners, the incumbent confirms the appropriate components required to support a CMC/Regional change in collaboration with the CMC/Regional Strategist and/or RCM Product Manager, confirms and/or establishes CMC/Regional content provision timelines and subsequently projectmanages their delivery to the appropriate colleagues. In parallel the incumbent assumes responsibility to assure product compliance through timely and accurate maintenance of CMC/Regional product information in both CMC/DE change management systems and regulatory planning and document management systems.
CMC change management/Regional planning and compilation can take place over days, weeks or months from trigger to completion and will involve coordination with others regarding components and standards required for multiple Boards of Health. Multiple CMC/Regional change types at different stages may be managed in parallel, related to product, dossier type or country assignments/requirements.
- Provide operational support within RCM team to execute designated tasks associated with CMC/Regional colleagues
- Package coordination activities for assigned products and/or at required CMC change management Process as appropriate
- Accountable for delivering tasks with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement
- Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved
- Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions
- Has Fundamental knowledge and skills of regulatory CMC submissions and ensure regulatory or business requirements are fulfilled
- Commit to completing required on-the-job training courses to ensure training compliance is preserved
- Promotes the use of Document Management systems and standard document publishing processes, partnering with supplier groups as necessary to produce timely delivery of submission ready components
- Execute regional specific CMC tasks to support on-time project delivery
- Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigor and risk.
- Command necessary knowledge and skills for on-time delivery of CMC submissions ensuring business requirements are fulfilled.
- Accountable for delivering category aligned submissions with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement
What You Will Achieve
You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
Important Interview Questions and Answers for the above job role:
- What is your experience in electronic submissions build within the Pharmaceutical Industry? Answer: I have 2-3 years of experience in electronic submissions build within the Pharmaceutical Industry. I have a good understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
- What is your experience in project management? Answer: While I do not have direct experience in project management, I have been responsible for coordinating activities in a highly regulated environment, which requires effective project management skills. I have experience in managing timelines, coordinating with multiple stakeholders, and ensuring timely and accurate delivery of tasks.
- How do you ensure regulatory compliance while working in a highly regulated environment? Answer: I adhere to applicable policy, SOP/Work Instructions, guidelines, or service level agreement to ensure regulatory compliance. I also use technical tools and adhere to working practices and QC/QA regimes to preserve regulatory and internal compliance.
- How do you manage multiple CMC/Regional change types at different stages simultaneously? Answer: I have experience in managing multiple CMC/Regional change types at different stages simultaneously by prioritizing tasks based on their importance, setting clear timelines and expectations, and communicating effectively with all stakeholders.
- How do you ensure on-time delivery of CMC submissions while fulfilling business requirements? Answer: I ensure on-time delivery of CMC submissions by staying up-to-date with the regulatory requirements and maintaining a good understanding of the drug development process. I also work closely with internal and external partners to confirm the appropriate components required to support a CMC/Regional change, establish content provision timelines, and project manage their delivery to the appropriate colleagues.
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