At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.
Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice with a positive, agile company culture and with well-defined ethical principles, values, and systems.
Everything we do is led by our company values of integrity, being patient centric, taking ownership, delivering results, and communicating openly. These values are essential to Astellas relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value driven life sciences innovator.
Purpose and Scope
- Responsible for the applications and approvals for new, renew products, variations of all Astellas products including biological products within the set time frame.
- Conduct in compliance with local regulatory agency requirements as well as relevant company policy and internal SOPs.
- Ensure timely and complete training in line with requirements for the role.
- Support local Drug Safety Officer (DSO) in managing the Affiliate Pharmacovigilance (PV) activities to ensure compliance with PV Astellas quality documentations and local laws and guidelines. Liaise within Affiliate and with PV-Affiliate Support Function colleagues on urgent matters impacting PV.
Responsibilities and Accountabilities
- Build and propose regulatory strategy for NDA/BLA of new modality, additional indication of current existing products and post-maintenance variations.
- Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence under the direction of AVN RAPV Lead.
- Prepare, submit registration dossiers including new, renewal product, variation, GMP clearance... under applicable laws and regulations and local standard operating procedures if applicable.
- Follow up with related experts to get the result for submitted dossiers timely.
- Follow regulatory related QDs, working procedures, checklist etc. to improve the quality of filing dossier and operational efficiency.
- Collaborate with related functions to ensure artwork and labeling comply with agency requirement and marketing promotion needs.
- Conduct the training in line with the requirement for the role.
- Support RAPV Lead to send the comment/feedback for draft/current laws/regulations.
- Provide document/expertise on tender document to Tender team: GMP/IPP listings/tender.
- Ensure that Regulatory Databases (Country Requirement Database, Product Approval Status, Approved Artworks, Marketing Authorizations, Approvals for Changes After MA approval) are up to date with accurate information consistent with the source document.
- Catch up on the latest VN regulations and convey proper interpretation to relevant stakeholders.
- Manage promotional material review.
- Management of Product Safety Information
- Ensures that product safety information received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards.
- Manage all Individual Case Safety Reports (ICSRs) in the applicable system(s) in accordance with applicable standards and procedures.
- Perform reconciliation activities with other Astellas operating unit systems (e.g. Medical Information and TrackWise for Quality Assurance) and contractual partners, as applicable
- Prepare the Periodic Safety Update Report (PSUR) submission in accordance with local regulations.
- Support DSO in the archiving of PV documents, ensuring that the documents have been archived correctly and completely.
Required Qualifications
- Bachelors degree (or higher degree) of Pharmacy or related major (Pharmacist preferred. MS degree preferred).
Preferred Qualifications
- At least 1 year experience in Regulatory Affairs and/or Pharmacovigilance function in Intl Pharmaceutical Companies
- Self-disciplined
- High level of integrity and good morals
- Excellent customer service skills addressing the needs of both external and internal customers with strong communication and process skills, problem solving, leadership skills, decision making skills, analytical skills, integrity
- Excellent English communication skills (verbal and written)
- Have sound knowledge about products and regulations
- Build teamwork and co-operation spirit
- Open-minded and approachable
- Results orientated and energetic - drives self and others to achieve and / or exceed targets for the benefit of the organization.
Working Environment
- This position is based in Hanoi or Ho Chi Minh City, Vietnam and will require on-site work.
- As RAPV is global organization, on-line meetings could happen at late night.
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines.
