Job Description
Regulatory Project Manager
Spektus Pharma | Montréal or Dubai | Remote considered
Build, lead, and scale regulatory execution for a fast-growing specialty pharma company.
Spektus Pharma is a specialty pharmaceutical company focused on developing innovative and value-added medicines for the Central Nervous System (CNS) disorders, addressing needs in areas such as depression, ADHD, and pain. With its proprietary drug-delivery platforms, including the patented Flexitab® breakable extended-release technology, the company delivers significant clinical benefits and new opportunities for established molecules. Headquartered in Laval, Quebec, Spektus conducts in-house research and development and collaborates with global pharmaceutical partners, mainly targeting the North American and European markets.
This is a high-impact role with direct exposure to senior leadership, global partners, and health authorities.
Key Responsibilities
Own and manage end-to-end regulatory project timelines across multiple programs (US, EU, Canada, ROW)
Coordinate regulatory activities across CMC, clinical, non-clinical, and manufacturing workstreams
Drive preparation and submission of NDAs (505(b)(2)), ANDAs, MAAs, variations, and lifecycle submissions
Act as the central interface between internal teams, CROs, CMOs, consultants, and partners
Track deliverables, risks, dependencies, and critical path items to ensure on-time filings
Support health authority interactions, responses to questions, and post-approval commitments
Maintain high-quality regulatory documentation, trackers, and dashboards for management and partners
Ideal Candidate Profile
5+ years experience in regulatory affairs or regulatory project management in pharma or biotech
Strong working knowledge of FDA and/or EMA regulatory pathways (experience with 505(b)(2) is required)
Proven ability to manage multiple complex programs in parallel
Experience coordinating cross-functional teams (CMC, clinical, QA, manufacturing)
Highly organized, detail-oriented, and comfortable operating in a fast-paced growth environment
Excellent communication skills with the ability to work directly with senior stakeholders
Background in CNS, oral solid dosage forms, or complex generics is an advantage
Preference for candidates based in Dubai (UAE) or Montréal (Canada), with ability to work in a hybrid setup
Why Join Spektus?
Play a core role in taking multiple products from late development to approval and launch
Work on innovative, differentiated medicines with clear patient and commercial value
Gain exposure to global regulatory strategy across the US, EU, and other key markets
Join a lean, entrepreneurial team with direct access to leadership and decision-making
Competitive compensation with opportunity to grow as the company scales
