We are growing, grow with us!
PharmaLex is one of the largest providers of Development Consulting and 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 to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
We are seeking experienced and motivated individuals to join our growing US team. The successful candidate for the Senior Manager, Strategic Integrated Product Development must have a minimum of 5 years of experience working for, or as a service provider to pharmaceutical or biotech companies. Regulatory Affairs and/clinical development experience is a pre-requisite for this exciting role. This is an exciting opportunity for career growth in developing strategic drug development expertise.
PharmaLex is a proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, 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.
As a Key Contributor You Will manage and work closely with PharmaLex consultants to craft and implement Product Development strategies including regulatory and clinical strategies. You will also support key regulatory agency meetings and submissions in support of the global development strategy. As appropriate, the Senior Manager provides project management technical, and regulatory expertise on US drug development programs to ensure development objectives and regulatory requirements are met and compliant with applicable regulations, guidance, and laws. When executing these responsibilities, the Senior Manager will adhere to PLx SOPs and working instructions applicable to the nature of the contracted work. The Senior Manager will be responsible for preparing and monitoring project plans, development milestones, regulatory strategies and recommendations. Additional responsibilities may include oversight of vendor activities, management of regulatory submissions (e.g. DMF, IND, CTA, NDA, or BLA), and leadership in interactions with FDA, EMA and/or other regulatory authorities.
Reports to (Title): Senior Director, Development Consulting Services
Travel Expectations (%): Up to 20%
Senior Manager, Strategic Integrated Product Development
- Research, interpret, and apply relevant regulations and industry guidance to inform product development/regulatory strategy and to meet client development objectives
- Advise clients on regulatory issues concerning their products and development programs; Partner with client's internal teams to assure development plans align with regulatory requirements; challenge client assumptions, when appropriate
- Work independently and collaboratively to prepare and manage project plans based on global regulatory and product development strategy
- Coordinate team meetings with internal and external stakeholders to discuss progress on the project plan and on final client deliverables; interact with various client disciplines, such as project management, CMC, clinical, nonclinical, marketing, pharmacovigilance, quality assurance, business development and corporate management
- Ensure deliverables are completed within agreed timeline, budget, compliance requirements, service standards and adequate resources’ competency levels so that a high level of client satisfaction is achieved
- Oversee and manage client activities that are outsourced to contract manufacturers, contract research organizations, and other vendors as needed; engage in vendor identification, prepare requests for proposal, conduct competitive bid analyses, and document PharmaLex recommendations for vendor selection.
- Represent clients at FDA, EMA, and other regulatory agency meetings
- Draft and manage regulatory submissions, annual reports, Investigator's Brochure, clinical and nonclinical study protocols, Orphan Drug Designation requests, Fast Track or Breakthrough Therapy Designation requests, Agency meeting requests, and other submissions as required.
- Keeps abreast of new and changing industry technical and regulatory requirements
- Identify scope changes in projects and manage accordingly, anticipating problems before they arise in a project
- Identify opportunities for additional work within current projects
- Identify leads and opportunities within clients outside of current project scope, include sales staff as appropriate to help discuss and scope those opportunities and turn them into proposals for new work
- Actively seek out new client relationships and new business opportunities on behalf of PharmaLex
- Attend trade shows and other events to represent PharmaLex
- Bachelor’s degree required, Masters or higher preferred, in a scientific discipline or closely related field
- Minimum of 5 years regulatory affairs and/or drug development experience, preferably within a pharmaceutical or biotechnology company or consulting environment
- Excellent industry knowledge and familiarity with the drug development process, US regulations, ICH, FDA, and EMA guidance, and the organization of the common technical document (CTD)
- Experience in understanding and organizing complex scientific, technical and/or regulatory documents
- Strong written, verbal, and presentation communication skills; experience with negotiation and persuasion
- Strong organization, analytical, and problem-solving, and time management skills
- Strong project management skills, with an understanding of managing customer expectations
- Strong interpersonal skills and ability to lead and coordinate a multidisciplinary team
- Ability to adapt under regularly changing conditions and competing priorities
- Ability to work independently and as part of a team
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.