Total 2 student affairs director job vacancies in Others category in Singapore

Sr. Spclst, Regulatory Affairs

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

The Sr. Spclst, Regulatory Affairs will work within the company’s Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations International Asia Pacific department in Singapore, Asia.

The Sr. Spclst, Regulatory Affairs supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole of the AP region.

WHAT YOU WILL DO

As a member of cross-functional team and for the assigned products, her/she will manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes.

This position requires a high-level expertise and knowledge of the regulatory landscape across the AP Region, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).

Responsibilities include, but are not limited to:

• Planning and managing regulatory operation projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities.
• Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Lead or participate in cross-functional forums and meetings
• Work closely with the central planner based in the HQ (US) on assigned products/projects.
• Drive the submission assembly and delivery process with the Global and/or Regional Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
• Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
• Maintain knowledge on the regional regulatory procedures on internal and external guidelines and standards.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

· Bachelor’s degree in a Life Science related discipline.

• At least 3-4 years’ experience in the regulatory operations area, regulatory affairs will be an asset.
• Able to multitask with proven project management capabilities including managing dynamic timelines, interacting, and negotiating with others, collaboration skill and excellent follow-up ability
• Thorough knowledge of regulatory guidelines and procedures within the AP region is required. and knowledge of submissions in the wider region is preferable.
• Excellent communication skills to manage interactions with colleagues in a multicultural environment.
• Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
• Ability to handle time pressure and the consequence of any delay in timely submissions.
• Affinity to work with complex IT systems.

What we look for…

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us — and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Associate Director, Quality Control, Site Microbiology SME

The position of Associate Director in Quality Operation will play a key role in supporting sitewide on the microbiology expertise, not limited to, Quality Microbiology Laboratory, Manufacturing and Utilities. The role will ensure and maintain high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Ensure inspection readiness of the area with respect to all self-inspections, internal and external audits. When required, provide responses and timely follow-up on relevant corrective actions and commitments made because of the inspections.
• Strategize and lead key Microbiology initiatives such as implementation of contamination reduction, sample optimization, etc.
• Manage escalations and senior stakeholders for the microbiology matters, including financial targets and related efficiency and productivity KPIs.
• Drive collaboration and transformational culture change.
• Ensure consistent execution of related safety programs to maintain a safe working environment.
• Technical support for microbiology deviations, including escalation and above site contact and review.
• Provide guidance, review, and approve as business owner for Quality topics relating to microbiology, environmental monitoring risk-based design Quality Risk Analyses and Contamination control strategy & plan.
• Technical reviewer for new qualifications, new methodologies, or facilities with major changes.
• Technical oversight of New Product Introduction, Technology Transfer, Method Development/Qualification.
• Provide advice and guidance in a consultancy capacity to stakeholders for sitewide microbiological issues.
• Point of contact with above site on microbiology matters.
• Support/lead MPS and continuous improvement initiatives regarding to microbiology.

What are we looking for?

Qualifications & Experience

• Bachelor’s degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
• Minimum 10 years of applied professional work experience in microbiology in pharmaceutical or sterile manufacturing.
• Demonstrated experience in change and project management with ability to communicate across sites.
• Experience and expert knowledge of regulatory standards, compliance procedures and quality systems especially for Singapore, EU or US markets.

Personal Qualities

• Demonstrated ability to influence/collaborate with stakeholders at senior levels.
• Customer focus with strong business acumen and continuous improvement mindset.
• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.
• Strong communication and interpersonal skills.
• Passionate in coaching and mentoring with a focus on creating an inclusive culture.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.