Offer summary

Qualifications:

Around 8-10 years of relevant experience in regulatory affairs, specifically with pre-approvals and post-approval lifecycle management of drug products., Working knowledge of EU and US regulatory procedures, with additional knowledge of ROW markets being advantageous., Experience in handling CMC-related health authority queries and a good understanding of regulatory frameworks for small and large molecules., Strong communication skills and the ability to mentor team members, along with experience in Regulatory Information Management Systems like Veeva Vault..

Key responsabilities:

Contribute to the preparation and delivery of regulatory maintenance submissions from a global and regional perspective.

Prepare and review Marketing Authorization Applications and Variations for various medicinal products, ensuring compliance with regulatory requirements.

Liaise with cross-functional teams to align on product responsibilities and maintain submission delivery plans.

Provide regulatory impact assessments for change proposals and prepare safety variations for Health Authorities.

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Around 8-10 years of relevant experience in handling of pre approvals (IND,NDA) and post approval life cycle management of drug products in various markets.
Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from a global and/or regional perspective.
Working knowledge of EU and US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
Experience in handling CMC related health authority queries
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
Preparation of documentation for different types of Variation procedures like Super grouping,
Grouping and Work-sharing to the Marketing Authorizations.
Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
Liaise closely with cross-functional members with aligned product responsibilities.
Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
Working experience in Regulatory Information Management Systems with emphasis on Veeva Vault.
Strong communications skills and ability to guide and mentor team members.
Ability to work independently and within stipulated time period.
To drive first time quality and efficiency on allocated project assignments.