Senior Regulatory Affairs Specialist, Pharma Job in Waltham 02451, Massachusetts Us
A career connection worth making
Meaningful connections. For someone with a renal condition, the smallest level of support and dependability can mean the world. That’s why Fresenius Medical Care North America is constantly looking for talented individuals who are focused on one thing: helping people live better lives. By joining a leading provider of renal care products and services, you’ll enjoy incredible growth and stability, but you’ll also play an important role in providing the consistent care that can make a real difference in our patients’ treatments. Now that’s a connection worth making.
Senior Regulatory Affairs Specialist, Pharma
Provide regulatory assessment and support, including the following activities:
Evaluate and assess regulatory impact of proposed product changes
Contribute to strategic planning as regulatory representative on interdepartmental drug development teams (see Relationships below)
Support product development teams by interpreting and strategically applying regulations, guidances, and available research/information.
Plan, prepare, and submit to FDA and other appropriate Health Authorities varied regulatory filings and correspondence. Keep to internal and federal timelines, and ensure that content, quality, accuracy and format of submission comply with applicable laws, regulations, and corporate standards
Critically review all types of documents for regulatory submission, including product labeling and promotional and advertising material
Conduct regulatory intelligence as required for in-licensing candidates and products in development
Ensure that all submission documentation, record keeping, and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements.
Maintain awareness of all current, pertinent regulations, guidelines, poli
BA/BS degree in a scientific discipline; graduate degrees a plus. 5-8 years regulatory experience in the pharmaceutical or biologics industries
Demonstrated working knowledge of scientific principles and regulatory requirements is essential, as well as the ability to interpret and strategically apply such knowledge
Previous experience in preparation of RA documents is required
Able to work independently with minimal direction
Able to work collaboratively in a team setting
Highly detail-oriented, well organized, and driven to meet deadlines and program goals
Excellent interpersonal, verbal, and written communication skills, including the ability to make effective and persuasive presentations
Good computer skills with knowledge of Microsoft Word (excellent), Excel (good), and Project (basic) and experience with Word templates
Prior experience with eCTD submissions highly preferred
