Regulatory Project Manager

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)

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Get Hired
• 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