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PharmaLex is one of the largest providers of Development Consulting and 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 to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
We are currently looking for an associate director 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, skill, 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 work with cross-functional teams and manage regulatory aspects of review and approval of communications and activities to ensure compliance with regulatory requirements.
Associate Director, Regulatory Advertising and Promotional Review
- With minimal guidance develop and management project work plans based on agreed client deliverables and timelines
- Provide specialized knowledge on Canada regulations and requirements governing product advertising, promotion and related communications, including pipeline and disease state communications, ensuring that regulatory requirements are integrated into communications
- Serve as Communication Review Committee Chair and regulatory reviewer for appropriate clients leading discussions between stakeholders (e.g., Commercial, Medical, Legal, Public Affairs) to reach consensus decisions
- Assess the regulatory context and provide regulatory interpretations of applicable guidances, regulations or regulatory precedents, including requirements related to submission of materials the Pharmaceutical
- Advertising Advisory Board
- Review Market Access materials for reimbursement-related submissions for public and/or private payers
- Serve as regulatory reviewer on Medical Review Committee (MRC)
- Provide guidance and input for development products reflective of promotional considerations
- Work with Marketing Agency for PAAB submissions, follow on communications and discussions with PAAB, incorporating PAAB comments into materials, and ensuring appropriate archiving of PAAB comments
- Ensure changes in product labeling are carried into promotional materials in accordance with procedures
- Collaborate in efforts to develop and update procedures and guidelines related to CRC processes
- Other duties as assigned
- Bachelor’s degree in Life Science or related fields with 8 years of experience; or equivalent combination of education and experience
- Thorough knowledge of and direct experience with applicable Canadian Health Authority codes, laws, regulations, guidances, and industry standards related to advertising and promotional communications about prescription drugs and investigational treatments (i.e., PAAB, IMC)
- General knowledge of applicable laws (CASL, F&DA)
- Good understanding of clinical study design and statistical analyses in assessment of promotional claims
- Experience using an Electronic Review System (e.g., Veeva PromoMats)
- Understanding of labeling development and requirements is a plus
- Experience facilitating cross-functional discussions
- Strong interpersonal and communication skills with ability to communicate difficult concepts and persuade others
- Fluency in English; working knowledge of French is a plus
- Excellent written, verbal and presentation communication skills
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.