Regulatory Affairs Consultant (Biologics)

8-9 years

Not Disclosed

Bangalore 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

Job Description

At Parexel, we believe that when our values align, we can achieve remarkable things. Our shared goal is to enhance global health. Whether through clinical trials, regulatory support, consulting, or market access, our commitment is fueled by a deep conviction in our mission. Every role at Parexel contributes to developing therapies that benefit patients. We approach our work with empathy and a personal touch, dedicated to making a meaningful difference.

Position Overview:

We are seeking a Regulatory Affairs professional with 8-9 years of experience in managing the pre and post-approval life cycle of biologic products across various markets, including regulated (EU, US, Canada) and emerging markets. The ideal candidate will possess a strong understanding of the regulatory framework and regional trends related to various application types and procedures.

Key Responsibilities:

Compile, submit, and secure approvals for country-specific submission files, including Marketing Authorization Applications (MAA), Life Cycle Management (LCM), and post-approval changes.
Contribute to the preparation and delivery of regulatory maintenance submissions, authoring sections as needed, and progressively taking on more complex submissions from both global and regional perspectives.
Assist affiliates in updating local regulatory requirements based on guidance from regulatory agencies and input from affiliates/distributors.
Demonstrate a thorough understanding of local and international regulatory guidelines.
Prepare and review Marketing Authorization Applications and Variations for a range of medicinal products in regulated and emerging markets.
Collaborate closely with cross-functional team members on product-related responsibilities.
Develop and maintain submission delivery plans and content plans, providing proactive status updates to relevant stakeholders.
Utilize Regulatory Information Management Systems, such as Veeva Vault, to support submission processes.
Exhibit strong communication skills, with the ability to work independently and collaborate effectively within a team.

If you are passionate about improving patient outcomes and have the relevant experience in regulatory affairs, we invite you to join us in making a difference at Parexel.

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Regulatory Affairs Consultant (Biologics)

Job Description

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