Post: Senior Regulatory Affairs Associate – Biologics
Job Description:
As a Senior Regulatory Affairs Associate at Parexel Consulting, you’ll play a crucial role in guiding biopharmaceutical and medical device companies through the complexities of regulatory compliance. Leveraging your scientific, technical, and regulatory knowledge, you will collaborate closely with clients to craft and implement effective regulatory strategies. These strategies will not only expedite the market entry of their products but also ensure sustained regulatory compliance.
We prioritize collaboration, innovation, and continuous learning. Joining our team means engaging with a diverse clientele across various product types and therapeutic areas. You’ll enhance your expertise through challenging assignments and mentorship from seasoned regulatory professionals. Enjoy the flexibility of remote work while being part of a supportive and dynamic team environment.
Candidate Profile:
- Experience: Approximately 4-8 years of relevant experience managing the pre and post-approval lifecycle of biologic drug products across multiple markets.
- Thorough understanding of global regulatory frameworks and regional trends for different types of regulatory applications and procedures.
- Proficiency in preparing and delivering regulatory maintenance submissions, progressively handling more complex submissions globally or regionally.
- Familiarity with EU/US regulatory procedures, including post-approval requirements; knowledge of regulatory legislations in ROW markets is advantageous.
- Expertise in addressing CMC-related queries from health authorities.
- Comprehensive understanding of regulatory frameworks and regional trends for diverse application types and procedures, covering small and large molecules across global pharmaceutical legislation and ICH guidelines, particularly in regulatory CMC aspects.
- Experience in preparing and reviewing Marketing Authorization Applications & Variations for various medicinal products (orals & parenterals) across EU filing procedures (DCP/MRP/National Procedures).
- Proficiency in preparing documentation for various Variation procedures such as Super grouping, Grouping, and Work-sharing for Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
- Conducting regulatory impact assessments for change proposals and identifying required documentation for EU submissions.
- Close collaboration with cross-functional teams responsible for product alignment.
- Execution and management of submission delivery plans, submission content plans, and proactive status updates to stakeholders.
- Preparation, review, and submission of safety variations to Health Authorities, alongside post-approval CMC-related updates.
- Experience with Regulatory Information Management Systems like Veeva Vault.
- Strong communication skills and the ability to mentor and guide team members.
Additional Information:
- Experience: 4-8 years
- Locations: Hyderabad, Telangana; Mumbai, Maharashtra
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Regulatory Affairs
- End Date: 30th June 2024
This position offers a challenging yet rewarding opportunity to make a significant impact in the regulatory landscape of biologics, supported by a globally respected organization committed to your professional growth and development.
