Senior Regulatory Affairs Associate-Biologics

4-8 years

Not Disclosed

Bangalore Hyderabad Remote

10 Oct. 1, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Regulatory Affairs Associate

At Parexel, we believe that when our values align, there are no limits to what we can achieve. Our unified mission is to enhance global health, and each clinical development solution we provide—be it through clinical trials, regulatory support, consulting, or market access—is driven by a profound conviction in our work.

Every member of our team plays a vital role in developing therapies that ultimately benefit patients. We approach our responsibilities with empathy and a personal commitment to making a meaningful impact.

Position Overview:

We are looking for a Senior Regulatory Affairs Associate with 4-8 years of relevant experience in managing the pre and post-approval life cycle of drug products, including both small molecules and biologics, across various markets.

Key Responsibilities:

Contribute to the preparation and delivery of regulatory maintenance submissions, progressively handling more complex submissions from global and regional perspectives.
Demonstrate a solid understanding of the regulatory framework and regional trends related to various application types and procedures.
Possess working knowledge of EU and US regulatory procedures, including post-approval requirements; familiarity with ROW market regulations is a plus.
Address CMC-related health authority queries effectively.
Prepare and review Marketing Authorization Applications (MAA) and Variations for various medicinal products (orals and parenterals) for filing in the EU, utilizing various procedures (DCP/MRP/National).
Prepare documentation for different Variation procedures, including super grouping, grouping, and work-sharing for Marketing Authorizations.
Conduct regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.
Collaborate closely with cross-functional team members to align product responsibilities.
Execute and maintain submission delivery plans and content plans, proactively providing status updates to stakeholders.
Prepare, review, and submit safety variations to health authorities, and manage post-approval CMC-related updates.
Utilize Regulatory Information Management Systems, such as Veeva Vault, to support regulatory processes.
Exhibit strong communication skills and mentor team members effectively.
Work independently while demonstrating a collaborative spirit.

If you are passionate about regulatory affairs and committed to improving patient outcomes, we invite you to join us at Parexel, where your contributions can truly make a difference.

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Senior Regulatory Affairs Associate-Biologics

Job Description

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