Regulatory Scientist - United States
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- Everyone who works at our company holds the same ambition – to transform the lives of people living with severe diseases.
- Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals.
- That’s why we ensure every colleague has the tools and environment to engage effectively in the work we do.
- Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization.
- To help us meet our ambitions and provide the best solutions to patients, our company is currently seeking a talented individual as a Regulatory Affairs Scientist
- Prepare and deliver regulatory operational plans for allocated projects/products.
- Project manage quality regulatory submissions to agreed project targets.
- Provide strategic and operational regulatory input and guidance in cross-functional teams.
- Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
- Support GRL to lead the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant company procedures and 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
- Bachelor’s degree in Science or related discipline
- 5+ years pharmaceutical experience with knowledge of Americas regional regulatory procedures and legislation
- 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 with an a high level of attention to detail
- 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
- Our company is a global biopharmaceutical company.
- We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people living with severe disease.
- With more than 7500 people in approximately 40 countries, our company offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.
- Thinking holistically, working together, championing change, delivering impactful results…these are some of the key competencies we are constantly developing, and looking for, at our company.
- Our company and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer.
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