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    Job · 16959859

    Pharmalex logo

    Specialist - Regulatory Informatics and Operations

    Pharmalex · Noida · onsite · Posted 42d ago

    Not disclosed3–5 yrsfulltimeSourced fromFoundit

    About a minute. You'll make an account on the way through.

    About this role

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

    Job Details

    Responsibilities

    • Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
    • Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5 for all applicable document types and Health Authority regions. Supporting pre-publishing, dossier compilation, dossier publishing and post-publishing activities.
    • Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support for informatics related Health Authority initiatives
    • Good understanding and working knowledge of US and EU eCTD submissions across all submission types.
    • Veeva Tool knowledge is preferred.
    • to be able to work in CET/US shift timezone.

    Qualification

    • B.Pharm or other Science degree, M.Pharm preferred

    Experience

    • Minimum 3 years of experience

    Skills & Knowledge

    • Submission publishing (mandatory) US Publishing experience
    • Veeva tool experience (preferred) Veeva Publishing experience

    Flexibility

    • Must be open to working in shifts if required

    What Cencora offers

    Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

    Full time

    Affiliated Companies

    Affiliated Companies: PharmaLex India Private Limited

    Equal Employment Opportunity

    Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

    The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

    Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call [phone removed] or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

    Sourced from foundit

    Skills

    Submission PublishingUS Publishing experienceVeeva Publishing experienceVeeva tool experience

    About Pharmalex

    Pharmalex logo

    Pharmalex

    Medical Equipment

    350

    employees

    1994

    32 years old

    Frankfurt am Main, Hesse

    Germany

    ₹6.6L PA avg

    Avg at Pharmalex

    About

    Pharmalex guides you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes, & post-approval activities.

    Industries

    Medical Equipment

    Employee ratings

    10 reviews

    3.2/ 5

    Culture

    3.3

    Career growth

    2.9

    Work-life

    3.3

    Employees rate it well for

    Overall Company32Company Culture31

    Find them on

    WebsiteLinkedInAmbitionBox reviews

    Specialist - Regulatory Informatics and Operations · waiting for your command