Pfizer Biotech Associate Job Opening – Online Application Process

Pfizer Biotech Associate Job Opening – Online Application Process

Pfizer Biotech Associate Job Opening – Online Application Process. Pfizer is hiring biotechnology candidates for an associate vacancy. Interested and eligible applicants can check out all of the details on the same below –

Job Title – Associate II – Reg CMC Strategy, Biologics

Job ID – 4861261

Location of Pfizer Vacancy – India – Chennai

• 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, 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 regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross functional teams and external partners to ensure regulatory data requirement and the deliverable dates are met.
• Negotiates submission data requirements and deliverable dates with stake holders on 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 ensure key submission deliverables assigned to the regional group.
• Responsible for ensuring compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. Suggests support and implements system improvements to ensure regulatory compliance, reduce cycle time and create efficiency.

Preferred Education:

• Bachelors or Master in Science / Pharmacy/ Biotechnology

Preferred Experience:

• Minimum 3 to 6 years of CMC experience within a regulatory function with knowledge of EU/US and international regulatory practices, 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 expertise to prepare and submit complex regulatory submissions related to Biosimilars
• Knowledge on ICH Quality Guidance
• Competency in understanding and interpreting regulatory requirements and 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.

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