Job Title: QRA/IRA Senior Executive
Company: Noronic Pharmaceuticals in collaboration with Neza Wellness
Summary:
Noronic Pharmaceuticals, in partnership with Neza Wellness, is seeking a highly motivated and experienced QRA/IRA Senior Executive to join our dynamic Regulatory Affairs team. This role offers a unique opportunity to leverage your expertise in dossier preparation, ACTD/CTD compilation, regulatory documentation, pharmacovigilance data, SMPC drafting, and global regulatory submissions. The ideal candidate will possess a strong understanding of global regulatory guidelines and a proven track record of successfully navigating complex regulatory landscapes. If you are a seasoned regulatory affairs professional looking to advance your career and contribute to a growing pharmaceutical company, we encourage you to apply.
Job Description:
As a QRA/IRA Senior Executive, you will be a key member of the Regulatory Affairs team, responsible for ensuring the compliance of our products with global regulatory requirements. You will work closely with cross-functional teams to prepare and submit regulatory documentation, manage regulatory queries, and maintain up-to-date knowledge of evolving regulatory guidelines. This role requires a strong understanding of pharmaceutical regulations, excellent communication skills, and the ability to work effectively in a fast-paced environment.
Key Responsibilities:
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Dossier Preparation (ACTD/CTD):
- Prepare, compile, and review ACTD & CTD modules, ensuring accuracy and completeness.
- Manage pharmacovigilance documentation, including safety reports and risk management plans.
- Oversee the preparation and review of stability data & reports, SPECT/Specifications, COA/MOA, and SMPC documents.
- Review BE study reports and prepare PDR (Periodic Drug Review) and AMV (Artwork Master Version) documents.
- Manage DMF (Drug Master File) submissions and ensure compliance of BMR (Batch Manufacturing Record) & BPR (Batch Packaging Record).
- Prepare BIT (Biological Information Template) forms and ensure CDP (Country Dossier Profile) matching.
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Regulatory Documentation & Approvals:
- Prepare and submit COPP (Certificate of Pharmaceutical Product), PP (Product Permission), and FSC (Free Sales Certificate) applications.
- Manage timely approvals, renewals, and follow-ups with regulatory authorities.
- Maintain accurate records of all regulatory submissions and approvals.
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Regulatory Queries & Communication:
- Handle country-specific regulatory authority queries, providing timely and accurate responses.
- Coordinate with international regulatory agencies and internal teams to address regulatory issues.
- Communicate regulatory requirements and updates to relevant stakeholders.
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Cross-Functional Coordination:
- Work closely with QA, QC, Production, R&D, and Marketing teams to ensure all required documentation is accurate and compliant.
- Provide regulatory guidance and support to cross-functional teams.
- Participate in product development and launch activities, ensuring regulatory compliance.
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Compliance & Continuous Improvement:
- Stay updated with global regulatory guidelines and best practices.
- Support dossier upgrades and SOP improvements to maintain compliance.
- Identify and implement process improvements to enhance regulatory efficiency.
- Participate in regulatory audits and inspections.
Eligibility & Qualifications:
- Experience: Proven experience in Regulatory Affairs within the pharmaceutical industry is essential.
- Education:
- B.Sc / M.Sc degree in a relevant scientific discipline.
- B.Pharm / M.Pharm degree is highly desirable.
- Strong knowledge of ACTD/CTD formats, regulatory submissions, and documentation requirements.
- Familiarity with global regulatory landscapes and guidelines (e.g., US FDA, EMA, ICH).
Preferred Skills:
- In-depth knowledge of global regulatory requirements for pharmaceutical products.
- Expertise in dossier lifecycle management, from initial submission to post-market surveillance.
- Strong documentation and communication skills, both written and verbal.
- Ability to coordinate effectively with cross-functional teams and external stakeholders.
- Solid understanding of QA/QC documentation and its relevance to regulatory submissions.
- Proficiency in using regulatory information management systems.
Benefits:
- Opportunity to work with leadership-level regulatory professionals and contribute to strategic decision-making.
- Exposure to global regulatory markets and diverse regulatory challenges.
- Skill enhancement through cross-functional collaboration and continuous learning opportunities.
- Career progression opportunities within a growing and innovative pharmaceutical company.
- Competitive salary and benefits package.
How to Apply:
If you meet the qualifications and are excited about the opportunity to join our Regulatory Affairs team, we encourage you to apply. Please send your updated resume/CV to [email protected]. We look forward to hearing from you!