Regulatory Affairs Specialist (Pharmaceutical)

Job overview/summary

CMC Regulatory Affairs Contractor while being a part of Global CMC RA organization serves as CMC RA Affiliate for assigned products and will primarily be responsible for planning, authoring and executing CMC submissions in Australia and New Zealand territories through partnership with Global teams and RA Affiliate and under CMC RA International Affiliate Team members guidance.

Job responsibilities

In this role for your assigned markets/regions you will

• Perform CMC change control assessments against local regulations, guidance, and best practices.
• Plan, author and submit CMC regulatory submissions including but not limited to clinical trial applications, amendments, supplements thereof, post-approval variations and periodic reports.
• Ensure regulatory conformance and consistency for assigned submissions in compliance with regulatory requirements and internal procedures.
• Ensure and lead timely discussion with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses
• Author and submit the responses to the health authorities with a sense of urgency.
• Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.
• Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
• Follow knowledge sharing practices using designated knowledge management tools and processes.
• Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country specific labeling.

Skills and Competencies

• A proven ability to author and co-ordinate preparation of a variety of CMC regulatory documents in collaboration with other functions.
• Strategic prioritization and implementation of risk-based approaches that includes analyzing, prioritizing, and mitigating regulatory risks.
• Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously and with tight timelines.
• Excellent verbal and written communication skills focused on delivering the right message to the right audience with an ability to convey information effectively with respect and cultural understanding.
• Excellent cultural awareness and appreciation. Ability to work efficiently with highly diversified individuals and groups of people.
• Growth mindset that enables open and rapid adaptation to change and new information, or unexpected obstacles. Ability to deal effectively with pressure; and remain optimistic and persistent, even under adversity.
• Willingness to take ownership and maximize benefits of empowerment.

Knowledge and Qualifications

• A scientific degree with 3 or more years directly relevant professional experience, preferably in small molecules CMC regulatory activities (biologics experience would be an advantage).
• Practical knowledge of ICH guidelines and Australian CMC regulatory requirements.
• Experience with authoring of CMC components of post approval submissions for small molecules
• Proven experience with submission compilation and filing technical variations of different complexity in EU and/or other countries with similar regulatory requirements to Australia/New Zealand. Direct experience with submissions in Australia/New Zealand is strongly preferred.

Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.

Job overview/summary

CMC Regulatory Affairs Contractor while being a part of Global CMC RA organization serves as CMC RA Affiliate for assigned products and will primarily be responsible for planning, authoring and executing CMC submissions in Australia and New Zealand territories through partnership with Global teams and RA Affiliate and under CMC RA International Affiliate Team members guidance.

Job responsibilities

In this role for your assigned markets/regions you will

• Perform CMC change control assessments against local regulations, guidance, and best practices.
• Plan, author and submit CMC regulatory submissions including but not limited to clinical trial applications, amendments, supplements thereof, post-approval variations and periodic reports.
• Ensure regulatory conformance and consistency for assigned submissions in compliance with regulatory requirements and internal procedures.
• Ensure and lead timely discussion with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses
• Author and submit the responses to the health authorities with a sense of urgency.
• Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.
• Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
• Follow knowledge sharing practices using designated knowledge management tools and processes.
• Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country specific labeling.

Skills and Competencies

• A proven ability to author and co-ordinate preparation of a variety of CMC regulatory documents in collaboration with other functions.
• Strategic prioritization and implementation of risk-based approaches that includes analyzing, prioritizing, and mitigating regulatory risks.
• Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously and with tight timelines.
• Excellent verbal and written communication skills focused on delivering the right message to the right audience with an ability to convey information effectively with respect and cultural understanding.
• Excellent cultural awareness and appreciation. Ability to work efficiently with highly diversified individuals and groups of people.
• Growth mindset that enables open and rapid adaptation to change and new information, or unexpected obstacles. Ability to deal effectively with pressure; and remain optimistic and persistent, even under adversity.
• Willingness to take ownership and maximize benefits of empowerment.

Knowledge and Qualifications

• A scientific degree with 3 or more years directly relevant professional experience, preferably in small molecules CMC regulatory activities (biologics experience would be an advantage).
• Practical knowledge of ICH guidelines and Australian CMC regulatory requirements.
• Experience with authoring of CMC components of post approval submissions for small molecules
• Proven experience with submission compilation and filing technical variations of different complexity in EU and/or other countries with similar regulatory requirements to Australia/New Zealand. Direct experience with submissions in Australia/New Zealand is strongly preferred.

Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.