Pfizer Regulatory affairs Jobs for Lifesciences Candidates

Pfizer inviting applications from Regulatory Affairs professionals experienced in New drug development (NDD) and Life cycle management (LCM) submissions with various Global Health
Authorities for our current job openings.

Regulatory Strategy position description:
To function as Global Regulatory Strategist responsible for developing and executing robust regulatory strategist (including CMC authoring and review) for the assigned products/projects.

Experience: 2-15 years in Pharmaceutical Regulatory Affairs function; experienced in authoring and review of high-quality
regulatory submissions (INDs/IMPDs/NDAs/ANDAs/MAAs/post- approval variations) in global markets (US, EU, Canada, AnZ &
RoW) for Sterile Injectables, Oral Solid Dosages (OSDs) and other dosage forms oncology, pharmacology, vaccines, and clinical,
computational, and genomic sciences

Labeling position description:

To function as Global Labeling Lead (GLL) with overall accountability for the initial creation and relevant updates to labeling documents and driving the labeling strategy for the
assigned products. This includes ensuring development and maintenance of CDS, USPI, SPC for products registered in EU and
their associated Patient Labeling documents.

Experience: 8-12 years of pharmaceutical labeling experience in content development and maintenance (CDS, USPI, SPC and other country labels etc.); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global / multi-national pharmaceutical environment) necessary. Experience at the country level important and advantageous.

Qualification: Minimum Postgraduate in Pharmacy / Life Sciences

Walk in Interview Information : Walk-in drive at Hyderabad on 14th and 15th May 2022
(9:00 am to 7:00 pm IST)

Venue: Lemon Tree Premier – Hyderabad
Plot No.2, Survey No.64, Hi-Tech City, Madhapur, Hyderabad 500081

pfizer regulatory affairs jobs4862566859086117218.
Pfizer healthcare Jobs; Regulatory affairs Mega walk in Drive at Hyderabad for Pharmacy & Lifesciences Candidates

2 thoughts on “Pfizer Regulatory affairs Jobs for Lifesciences Candidates”

  1. Raghuram Krishna

    I am Raghuram Krishan professionally having 18 years of Total experience challenging career in Quality Assurance, Development Quality Assurance and Regulatory Affairs of Pharmaceuticals Documentation as per ICH Q7A, Q8, Q9 & Q10,GMP, cGMP, Regulatory Norms and International Standard Organization (ISO) Quality Systems in Pharma industry. Proven expertise in Quality Assurance w.r.t 21 CFR Part 211, Data Integrity and Reliability, Quality Compliance Training, QMS, QRM, Strategic Management GMP & GLP. Supervised end-to-end Project Management functions including Project Planning, Support on Formulation developments w.r.t quality assurance for regulatory filings IND, ANDA, NEC-1, 505b(2) and Para-IV, EU and ROW markets.
    Certificate of Laboratory Management system and Internal Audit as per ISO/IEC 17025:2017requirement and leading the department from above 10 years of experience

    Participated in Regulatory and Customer Audits:

    USFDA Audits – 2 times face to face & one Virtual on product specific (Shilpa Medicare Limited Unit-III), WHO & ANVISA (Dr. Reddy’s FTO-II), UGANDA, MHRA, TGA, MCC & Health CANADA (Medreich limited), ISO- Management Representative for ISO 9000 Quality Systems. Customers- Faced several audits from internationally renowned companies.

    Key Skills:

    ➢ Sound experience in various functions in the manufacturing of Injectables & solid oral dosage forms.
    ➢ Adherence to cGMP, GMP & GDP across different stages of finished product manufacturing.
    ➢ Key analytical skills including review and Compliance checks.
    ➢ Implementation of procedures to comply with the regulatory requirements.
    ➢ Effective review of audit trails.
    ➢ Investigations
    ➢ Quality management system
    ➢ Qualification of Instruments / Equipment’s, Utilities & Facility of commercial units
    ➢ Sound experience in Vendor / Supplier Qualifications
    ➢ Decision make, team management w.r.t work plan & targets, team motivations & Trainings on regular power point presentations on current Regulatory requirements.

    Please check and do needful, if any suitable position in your organisation

  2. Dear Sir/madam,

    I would like to express my interest in your company. I am pretty confident that I will be an asset for your organization.

    I’ve attached a copy of my CV which contains all the details .

    Please feel free to reach me anytime on my cell phone or email address. Thank you for your time and consideration. Eagerly looking forward to speak to you.

    Sincerely,

    LUCKY SINGH

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