Regulatory Project Manager
Spektus Pharma | Montral 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 Montral (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
