Reg Associate Manager I - Product Variations

GSK India

3 - 4 years

20 - 25 Lacs

bengaluru

Posted:3 weeks ago| Platform:

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Skills Required

procurement pharma manager technology oncology hr subject matter expert recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

Independently and confidently executes agreed dossier strategy.
Minimum of 5 years of experience in CMC
bachelors degree in Chemistry , pharmacy or other related science or technical bachelors degree.
Independently manages multiple BioPharm project assignments simultaneously; assignments will range in complexity, but more complex work is expected .
Independently completes data assessment to ensure dossier is fit for purpose.
Identifies risks associated with submission data and information packages.
Escalates issues with line manager that have business impact.
May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff .
Understands internal/external Regulatory environment.
Actively builds an organizational network (GSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK

Preferred Qualification

Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
Global Regulatory submission experience - Knowledge of regulatory agency guidelines
Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
Ability to build effective working relationships and work in a matrix environment effectively
Ability to think flexibly in order to meet constantly shifting priorities and timelines

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