Senior Regulatory Affairs Manager- Singapore - Remote

Worldwide Clinical Trials - APAC; Singapore; Remote; SGD 90,000 - 120,000; Full time

Job summary

A global contracting organization in Singapore seeks a Regulatory Affairs Manager. You will oversee project regulatory activities, ensuring compliance with local and international regulations. The ideal candidate will have at least 7 years of experience within the pharmaceutical/CRO industry and demonstrate strong leadership and communication skills. This role offers a collaborative environment with opportunities for professional growth.

Benefits

Collaborative work environment

Opportunities for professional growth

Qualifications

• A minimum of 7 years of experience in the pharmaceutical/CRO industry.
• Proficient in cross-cultural communication.
• Required understanding of ICH GCP Guidelines.

Responsibilities

• Oversee day-to-day operations of the Regulatory Affairs team.
• Ensure project regulatory activities are compliant.
• Provide expert regulatory advice and contribute to regulatory project work.

Skills

Strong communication skills

Leadership and management skills

Organizational skills

Proficiency in MS-Office

Understanding of clinical research principles

Education

Bachelor's degree in related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

*SUMMARY: Oversees and contributes to the day-to-day operations of the Regulatory Affairs team to ensure project regulatory activities are conducted in accordance to Worldwide and sponsor requirements. Project activities include central and local EC submissions, Competent Authority submissions and any other country and/or study specific regulatory activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Reports to the Head of Regulatory Affairs group. This role has project-specific dotted line reporting to the Site Activation Manager or Site Activation Portfolio Manager if assigned to a portfolio or program of studies*

*RESPONSIBILITIES:*

_Tasks may include but are not limited to:_

Provides expert regulatory advice and contribute to regulatory project work
Participates in business development activities by contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and other country and/or study specific requirements or activities necessary for Site Activation
Stays currently informed as a subject matter expert of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
Complies with SOPs, ICH GCP and national regulations as applicable
Reviews and makes expert recommendations on all relevant study regulatory documentation e.g. labels, patient information sheets, diary cards etc. to ensure compliance with ICH GCP & country specific requirements
Fosters professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
Leads or contribute towards the preparation of technical /master study documentation in accordance to the study requirements, contracted scope and specific legislations
Oversees the activities of assigned Regulatory Specialists to ensure critical path activities are completed on time and ensures optimal start and conduction of regulatory affairs activities to meet project deliverables
Skillfully communicates the submission status to the Sponsor, GPL and relevant functional leads
Ensures high quality performance of deliverables are applied within the projects assigned to line reports and promptly identify and address any risk/potential risk by implementing preventive measures and mitigation plans in collaboration with the Site Activation Manager
Supports training and guidance for junior members of the Regulatory Affairs team
Provides expert regulatory knowledge with the Site Activation functional leads and the rest of project team to establish risk mitigation strategies/contingency plans and present these to sponsors
Ensures high quality, completeness, consistency and accurate tracking, and prompt filing of submissions and response to queries in accordance with SOP's and regulatory guidelines
Manages regulatory affairs team workload and provides input as to shifting of resources, allocations etc. to respond to projects demand (including holidays approval and proper back-up)
Conducts routine performance review of line reports and ensures performance feedback is promptly communicated in parallel with coaching
Participates in the development and maintenance of departmental processes, tools, policies, SOPs and associated documents
Assists the Site Activation leadership team and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary
Supports maintenance of the regulatory intelligence database by regularly following any changes in the regulatory legislative requirements
Development and delivery of regulatory training sessions

Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

*OTHER SKILLS AND ABILITIES:*

Strong oral and written communication skills to clearly and concisely present information
Strong and proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint, regulatory portals and all Worldwide applications
Expert understanding of clinical research principles and process
Expert knowledge of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
Strong ability to work in an organized, methodical and self-motivated manner
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problem

*REQUIREMENTS:*

A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR...
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
Proficient in cross-cultural communication and proficient in both spoken and written English

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.