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Nonclinical Scientist, Regulatory Affairs & Product Development
Job Description
Duties:
Job Title: Nonclinical Scientist, Regulatory Affairs & Product Dev
Regulatory Affairs
Regulatory Affairs & Product Development is responsible for nonclinical development consulting to provide innovative solutions and regulatory submissions for all aspects of pharmaceutical, biologics and device development from discovery through post-approval maintenance.
Job Duties:
- Utilizes broad and deep knowledge to develop innovative new business practices, policies, and procedures.
- Contributes to the development of department strategy.
- Works on or may lead highly complex projects of large scope.
- Projects are typically cross-functional and have significant and long-term impact.
- Provides solutions which set precedent.
- Negotiates complex or risky technical business issues on behalf of the company.
- Independently defines project establishes budgets identifies participants and mitigates risk.
- Consults with management to determine project objectives with long-term implications.
- Acts as a mentor to less experienced colleagues
• 12+ years of experience, preferred
• Ability to work independently
• Strong knowledge of regulations/guidelines required
• Scientific and technical reading, writing and editing skills required.
• Well-developed organizational, interpersonal and communication skills, and the ability to develop and present varied and unique ideas.
• Good working knowledge of MS WORD, Adobe Acrobat, Project, Powerpoint and use of one or more electronic document management systems
Education:
Bachelor's degree in related field, or equivalent work experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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