PharmaLex is one of the largest providers of Development Consulting & Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.

We are currently looking for an experienced Senior Manager to support our Regulatory Affairs Team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.

PharmaLex is a proud to be an equal opportunity employer. We respect and seek to empower each individual, and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

As a Key Contributor You Will provide Regulatory Affairs (RA) technical expertise and consulting for US/Canada projects.

Reports to (title): Head of Regulatory Affairs, North America

Number of direct/indirect reports: TBD

Provisional budget: N/A

Travel expectations (in %): up to 10%

Key Responsibilities and Activities

• Act as a key regulatory affairs consultant, providing expertise and innovative solutions to clients and internal teams on US and Canadian regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications.
• Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution.
• Lead cross-functional submission teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy.
• Ensure timely preparation, review, and submission of documents to regulatory authorities, and ensure compliance with applicable regulatory requirements.
• Coordinate, prioritize and track regulatory activities and submissions associated with clients’ research, development, and post-marketing activities for a variety of therapeutic areas.
• Manage budgets, client expectations, and project delivery for global projects.
• Prepare Module 1 documentation for US and Canadian Regulatory filings.
• Maintain knowledge of changing regulatory requirements and advise teams as appropriate (Regulatory Intelligence).
• Represent client regulatory affairs team as needed.
• Identify potential regulatory risks to the operational plans and propose options to mitigate risks.
• Draft and manage regulatory submissions, such as new INDs, IDEs, annual reports, Investigator's Brochure, clinical and nonclinical protocols, NDA/ANDA/BLA, MAAs, and other submissions as required.
• Liaise with regulatory authorities on behalf of clients (e.g., US Agent).
• Build, develop, maintain, and expand working relationships with clients.
• Support marketing, business development and sales activities to drive new business through proposal writing, pricing, budget estimates, presentations, etc.
• Oversee Regulatory Affairs project forecast, budget, scope, and resources.
• Assist to continually improve North American Regulatory Affairs processes.
• Supervise, guide and train junior staff.

Required Education, Experience, Skills and Competencies

• 5+ years of experience and broad knowledge in the field of Regulatory Affairs, especially generics, prescription drugs and biologics (food, dietary supplements and veterinary drugs experience is a plus).
• Experience with planning, preparing, and filing FDA IND/ANDA/NDA/BLA original applications, IND/ANDA/NDA/BLA maintenance submissions, HC CTA/IMPD/NDS.
• Good understanding of the North American regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelines.
• Experience with US labeling is a plus.
• Strong critical thinking and leadership skills
• Results focused approach.
• Ability to work in a growing, fast-changing environment and adapt to resource and knowledge gaps in client and internal RA teams.
• Excellent skills in moderating and presentation.
• Strong command of the English language.

• This is a remote position.

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