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Sr Spec, Regulatory Affairs
Job Description
Target PR Range: 40-50/hr
*Depending on experience
Summary:
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.
Key Responsibilities:
- Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
- Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
- Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
- Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.
- Other incidental duties assigned by Leadership.
Additional Skills:
- Coursework, seminars, and/or other formal government and/or trade association training required
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Good written and verbal communication skills and interpersonal relationship skills
- Good problem-solving, organizational, analytical and critical thinking skills
- Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
- Solid knowledge and understanding of global regulatory requirements for new products or product changes.
- Solid knowledge of new product development systems
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build productive internal/external working relationships
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Education and Experience:
- Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
- 5-7 years of experience required
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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