Pharmacy Regulatory Associate Vacancy @ Pfizer – Apply Online
Pfizer hiring Associate. B Pharma and M Pharma associate. Pharma job opening 2022. Pharma job vacancy. B Pharma & M Pharma apply for the job vacancy at Pfizer. pfizer announces job opening for pharma candidates. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Associate II – Reg CMC Strategy, Biologics
Location: India – Chennai
Eligibility Criteria: Bachelors or Master in Science / Pharmacy
Preferred Experience:
Minimum 3 to 6 years of CMC experience within a regulatory function with knowledge of EU/US and international regulatory practices and policies.
Preferred Attributes:
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.
Technical Skills:
Knowledge on the Regulatory requirements for Biosimilars development and life cycle changes for US and /or Europe and has the expertise to prepare and submit complex regulatory submissions related to Biosimilars.
Knowledge on ICH Quality Guidance
- Competency in understanding and interpreting regulatory requirements and the emerging regulatory landscape for Biosimilars
- Ability to understand and communicate scientific and clinical information
- Ability to comprehend and summarize complex technical data.
- Intermediate level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
Job Description:
- Functions as GRS CMC to assess a post-approval change, define the Global Regulatory submission strategy in collaboration with the Project/CMC Leads, and ensure timely and quality regulatory submissions for on-market products. On-market includes supporting manufacturing sites and compliance issue management.
- Functions as GRS CMC for Biologics development projects and the lifecycle changes works with Project/CMC Leads, cross-functional teams, local and regional regulatory colleagues, and external partners (in case of in licensed products) to frame and drive global regulatory strategies and Global submissions.
- Manages the preparation and maintenance of core dossiers for original applications and subsequent changes and coordinates responses to deficiency letters with the assistance of local and regional regulatory colleagues.
- Provides adequate support and guidance to the team for authoring regulatory submissions and ensures effective data presentation and quality.
- Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e Module 1, Module 2.3, M3. 2S/P/R under guidance from the CMC GRS as appropriate and within agreed timelines.
- Advices Biosimilars programs on the regulatory requirements, coordinates and presents regulatory data needs and negotiates with and influences management, cross-functional teams and external partners to ensure regulatory data requirements and the deliverable dates are met.
- Negotiates submission data requirements and deliverable dates with stakeholders on a need basis.
- Remains knowledgeable and maintains awareness about current regulations and guidance related to Biosimilars, interprets, assesses its impact on product development programs and communicates to necessary stakeholders.
- Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team.
- Responsible for effective coordination and collaboration with the regional regulatory leads to ensures key submission deliverables assigned to the regional group.
- Responsible for ensuring team compliance to the submission standards, procedures and policies framed by Global Regulatory Affairs. Suggests supports and implements system improvements to ensure regulatory compliance, reduce cycle time and create efficiency
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