PharmaLex is one of the largest providers of Development Consulting & Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
We are currently looking for an experienced Senior Manager to support our Regulatory Affairs Team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude, and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
PharmaLex is proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.
Key Responsibilities And Activities
Accountable for the execution of projects in the field of regulatory, technical, and quality management consulting predominantly in the medical device and diagnostic sectors
Support more senior colleagues with their client-related work and assist junior colleagues as required
Support the organization with any relevant operational needs
Advising, supporting, managing regulatory, technical, and quality management consulting projects for clients in the medical devices and diagnostic sectors
Supporting PharmaLex staff and their customers in the implementation of medical devices and diagnostic regulatory strategies
Ensuring optimal licensing for marketing and regulatory compliance of complex products
Preparing, revising, and compiling product information for clients (e.g. IFUs, PIL, labels)
Creating, revising, editing, and maintaining technical dossiers and regulatory documentation for clients
Preparing and participating in Scientific Advice Meetings with regulatory authorities
Preparing and presenting seminars and lectures within their area of expertise to PharmaLex-internally and to clients and professional audiences
Communicating with the client and the Health Authorities within area of expertise (e.g. jurisdiction, process, or product)
Training and mentoring less experienced colleagues in consulting practices, regulatory frameworks and in client project work
Contributing to the optimization of departmental internal processes
Actively contributing to the sharing of knowledge within the Medical Device / IVD department
Participating in strategic regulatory issues (e.g. Regulatory consultations)
Supporting the preparation, quotation, and invoicing o of Projects in close cooperation with the respective Project Lead
Providing support to more senior colleagues in complex or strategic client-related work, including representation at business development meetings, conferences and in marketing activities
Key Decisions made by role
Without checking with your supervisor
Day-to-day client interaction and project portfolio management
Delivering consultancy services as per agreed Statement of Works (e.g. regulatory research, report compilation, technical advice)
Identifying next project steps with Clients and participating in the establishment of relevant Statements of Work
Directly managing service delivery within the project scopes, budgets and raising project risks to supervisor
Supporting junior and senior staff with their project work
Readily sharing knowledge in relevant technical disciplines (e.g. Regulatory, Quality Assurance and technical fields)
Suggesting Quality System modifications, document revisions and internal audit
After checking with your supervisor
Supporting internal Quality System activities (e.g. CAPAs, Audits) as per operational needs
Attending or participating in conferences, industry working groups and consultations, etc
Assisting with the preparation and delivery of training sessions
Initiating new client contacts
Releasing new Statements of Work to Clients
Conducting business development activities and other significant business-related activities
Delivering business-critical advice to clients (e.g. commercial & compliance strategies)
Acting on new business development and marketing activities
Actions recommended to your supervisor
Releasing high value client reports
Raising opportunities related to business operations, service promotion and structure
Recommending staff development needs
Required Education, Experience, Skills and Competencies
University degree in Science or Engineering
6 + years in regulatory and/or quality management in medical device, diagnostics, biotechnology, or related consulting environment
Hands-on experience in the preparation of regulatory and technical submissions, reports, and documentation or in the implementation of quality management systems (e.g. ISO 13485, ISO 9001, 21 CFR 820, MDSAP or equivalent), preferably in the medical device or diagnostics environment
ASQ/Exemplar Global Certified Auditor is a plus
Regulatory Affairs Certification from RAPS is plus
Sound understanding of local and international regulatory and compliance legislation and requirements
Ability to efficiently obtain and review information from a range of sources
Ability to interpret, analyse, plan, write and apply appropriate legislation, regulatory, technical, and quality requirements
Ability to identify and understand the commercial context of Clients and make project decisions accordingly
Ability to prepare regulatory documents and reports that are accurately referenced, with appropriate citation and written in cohesive manner to optimise outcomes
Identify up selling opportunities within their project portfolio
Complex problem-solving abilities, strong understanding of the consulting business
Structured, analytical, systematic, and independent approach to work
Team player with collaborative work style and willingness to knowledge share
Client orientation
Effective written and spoken communication skills with internal and external customers, colleagues and supervisors
Flexible and adaptable
Experienced user of the MS-Office package, Adobe Acrobat, and database systems
English and Spanish language fluency, written and spoken
*This is a remote position.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
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Seniority level
Director
Employment type
Full-time
Job function
Health Care Provider
Industries
Internet Publishing
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