UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system. With more than 8500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive. Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.
Post : Regulatory Scientist
Job Description:
• Prepare and deliver regulatory operational plans for assigned projects/products within a specific region
• Provide strategic and operational regulatory input and guidance in cross-functional team
• Manage quality regulatory submissions to agreed project targets
• Work flexibilty within and across regions to provide broad operational support to ensure the delivery of product team and business objectives
Accountability/Responsibility:
- Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations.
- Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
- Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
- Delivers project assignments supporting the business e.g. representation on functional workstreams
- Ensure that appropriate, up-to-date records are maintained for compliance
- Assist in development of regulatory standards and SOPs
- Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
- Assist in due diligence activities for in-licensing opportunities
Candidate Profile
Bachelor’s degree in Science or related discipline; Master's degree preferred 5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
Skills and Capabilities:
• Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations.
• Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
• Results focused – ability to overcome obstacles and achieve key outcomes
• Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
• Organizational Skills
• Integrity – overriding commitment to integrity and high standards in self and others
• Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
• Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
Additional Information:
Experience: 4 years
Qualification: Bachelor’s Degree
Location: Thailand; Philippines; Malaysia; Indonesia; India
Functional Area: Transportation Services
Industry Type: Pharma/Biotech/Clinical Research
End Date: 25th April, 2018
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