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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
