Description:
Title: Regulatory Scientist

Location: Raleigh, NC

Schedule: Full-time - Permanent or Freelance

TalentSource Life Sciences is currently searching for an experienced Regulatory Scientist to join one of our biotechnology partner companies. This is a full time opportunity, open to both employees and contractors, where the successful candidate will be working on studies dedicated to one client . This is an office based role, either in Atlanta, GA or Raleigh, NC.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

The Regulatory Scientist prepares and delivers regulatory operational plans for assigned projects/products within a specific region, in addition to strategic and operational regulatory input and guidance in cross-functional teams. The Regulatory Scientist manages quality regulatory submissions to agreed project targets and works flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

Major Accountabilities and Responsibilities

• Support the Global Regulatory Leader 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 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
• 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
• Assist in due diligence activities for in-licensing opportunities

Required qualifications

• Proven pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
• Albility to build effective partnerships; identifies opportunities and takes actions to build effective relationships within team and with other areas
• Strong influencing skills; through well thought through rationale and effective communication skills, able to influence key decisions
• 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
• Strong organizational skills
• Integrity; overriding commitment to integrity and high standards in self and others

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002007

If you would like to discuss the role before applying through the website, please contact holly.price@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE?

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters location is in Verona Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and regarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs, Reg Affairs, Regulatory Scientist, Biotechnology, Biotech, Pharmaceutical, Outsourced, Full Time

Skills: Scientist, Regulatory, Biotech, Pharma, Pharmaceutical Location: United States - Raleigh (NC) Share:

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