Regulatory and Compliance Project Manager (H/F)/x)

We are currently seeking a Regulatory and Compliance Project Manager with combination products experience to join our growing team and independently lead an end-to-end submission process. The role will require hands-on experience in Technical Files, IND, NDA, and BLA submissions specific to the US and EU markets.

Reporting to the Regulatory and Compliance Leader, within the role, you will: Responsibilities : Collaboration With a Cross-functional Customer-facing Team (Sales, CTS, Marketing, Quality & Supply) And With The Support Of Technical Functions (R&D Insight Centers, Manufacturing Plants & Central Quality) Is To Support Customers Located In the world (EU, America, Asia )

• Provide fast & accurate solutions to customer registration challenges (submission, variations, response to questions) in key geographies targeted by customers (Target WW markets)
• Deliver unique regulatory affairs Services in accordance with the timelines
• Collaborate with the Regulatory & Compliance Engineers and Specialists in the different Insight Centers and the Plants to prepare the different deliverables.
• Provide regulatory insight, interpretation and advice to technical/supportive teams internally on new/updated regulatory requirements
• Participates on a team to drive strategic regulatory direction for pharmaceutical client programs including
• Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
• Establish sound regulatory advice/position on key development issues, and communicate to the respective stakeholders
• Conduct risk assessments, managing critical issues and regulatory body interactions
• Provide high-level review of client programs and develop strategic plans for clinical, analytical, and process development
• Ensure development programs are compliant with local country regulatory requirements
• Initiate, author and/or collaborate on SOP’s, work instructions and Workflows for the regulatory operations function.
• Ability to author clear and concise regulatory documents (eCTD modules) with oversight of all documents for regulatory submissions and associated messaging
• Work closely with the development team to insure overall regulatory strategy
• Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison.
• There is a travel requirement of up to 30%
• Remote working 2 days a week

Core Competencies, Knowledge and Skill Requirements :

• Masters / Engineering / Pharmacist degree required. Degree in a scientific discipline or closely related area required. Typical majors include biochemistry, biological sciences, chemistry, pharmacy, toxicology, and medical device engineering.
• Minimum of 3 to 5 years of experience in the medical device or pharmaceutical industry required; ideally in quality design or regulatory compliance or regulatory affairs.
• Experience in development and commercial product lifecycle (Phase 1-3, Marketed combination products).
• An understanding of Technical Files, DMF, IND, BLA, NDA, MAA, and combination products processes.
• Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including customers, Notified Bodies, FDA, and other Health Authorities.
• Ability to report, prioritize and handle multiple projects simultaneously.

Communication & Interpersonal Skills

• Fluency in English and French (TOEIC or TOEFL score).
• Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.
• Proven ability to build trust and respect within the organization and external partners.

Significant Contacts

• Interacts with Nemera employees and management.
• Interacts with customers, external business partners and Regulatory Agencies