REGULATORY AFFAIRS ASSOCIATE

Regulatory Affairs Associate Location: Alameda, CA Category: Regulatory Affairs Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Apply For This Position Job Description The Opportunity As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You’ll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. What Youll Work On – Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. Assist with promotional content development and review for compliance before distribution. Assist in Regulatory Affairs Ad & Promo SOP development and review. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed Determine and communicate promotional content and approval requirements to cross functional teams. Assist compliance with product post-marketing approval requirements as needed. Required Qualifications – Bachelor’s degree or an equivalent combination of education and work experience Minimum of 2 years experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance,, research and development/support, scientific affairs, operations, or related area. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Write and edit technical documents. Negotiate internally. Pay strong attention to detail. Manage projects. Create project plans and timelines. Think analytically and critically. Organize and track complex information. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Apply business and regulatory ethical standards. Preferred Qualifications – Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields. 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired. Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Office programs skills to include Word, Excel, PowerPoint, Visio and SharePoint. Pay ranges between 30-36/hr based on 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(opens in new tab) 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. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.