We are growing, grow with us!

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 manager to support our regulatory operations 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 a 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.
As a Key Contributor You Will publish and deliver high quality, timely, and compliant regulatory submissions in eCTD format to global health authorities on behalf of PharmaLex clients and provide Regulatory Operations technical expertise and consulting for US/Canada projects.
Reports to (title): Head of Regulatory Operations North America
Number of direct/indirect reports: N/A
Provisional budget: N/A
Travel expectations (in %): 10%

Manager, Regulatory Operations

Your Job

  • Submission planning, management, and publishing of IND/NDA/BLA/ANDA/DMF/NDS/CTA applications and subsequent maintenance submissions.
  • Management of Regulatory Operations projects, including communication with clients and authorities.
  • Technical preparation of regulatory source documentation, e.g. MS Word formatting, creation of hyperlinks and bookmarks, according to applicable standards (i.e. FDA's PDF Specifications).
  • Creation, compilation and validation of electronic submissions (e.g. eCTD) for all types of regulatory activities (e.g. original applications, amendments, supplements, product correspondence, etc.) in ICH and non-ICH-areas using available software.
  • Electronic submission of dossiers to competent authorities via electronic submission gateways and applicable portals.
  • Assist to develop processes around and manage template suites.  Work with template provider to update and/revise templates.  Train clients and colleagues on template installation and use.
  • Act as a key regulatory operations consultant, providing expertise and innovative solutions to clients and internal teams on regulatory operations, process, filing, best practices, etc.
  • Maintain knowledge of changing regulatory submission technical requirements and advise teams as appropriate (Regulatory Intelligence).
  • Support consulting for clients concerning implementation and optimization of electronic submissions and document management systems.
  • Administration of docuBridge and other software specific to Regulatory Operations (e.g. updates, validation, maintenance).
  • Acting as interface to IT department regarding Regulatory Operations systems and tools).
  • Testing of electronic tools for new requirements concerning regulatory operations: requirements for validation, changes in eCTD-structure.
  • Training of Regulatory Operations topics, software solutions and requirements stipulated by authorities within and outside of Regulatory Affairs.
  • Training on Regulatory Operations topics, software solutions and requirements required by authorities.
  • Quality assurance in the field of Regulatory Operations (e.g. preparation of SOPs and WIs and corresponding training).
  • Customer care and acting as an interface with the clients and the team members within PharmaLex. 
  • Close collaboration with teams across all PharmaLex sites.
  • Support marketing, business development and sales activities to drive new business through proposal writing, pricing, budget estimates, presentations, etc.
  • Supervise, guide and train project teams and junior staff.

Your Profile

  • Minimum of 3 years of experience in Regulatory Operations.
  • Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on Regulatory Operations aspects
  • Ability to implement tactical goals of customer or internal projects within daily work
  • Structured, analytical, systematic and independent manner
  • Capability of supervision, prioritization and processing of parallel projects and tasks
  • High service orientation
  • Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
  • Professional written and spoken communication skills with internal and external customers, colleagues and supervisors.
  • Experienced user of the MS-Office package, Adobe Acrobat and database systems
  • English language fluency, written and spoken
  • Positive attitude
  • Capability of supervision, prioritization and processing of parallel projects and tasks
  • Excellent team player

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.