• Oversee projects ensuring adherence to applicable laws, regulations, and internal policies while driving successful project outcomes. • Spearhead the creation and implementation of compliance programs, transforming compliance requirements into actionable project plans. • Monitor project progress and compliance metrics, set ambitious yet achievable deadlines, and ensure high standards. • Act as the key liaison between compliance teams, project stakeholders, and department heads, fostering clear communication. • Conduct risk assessments to identify compliance gaps and project risks, and implement corrective actions. • Complete projects that meet compliance standards and set new benchmarks for quality and efficiency, ensuring certifications like ISO27001 are achieved.

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content. • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development. • Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification. • Training and oversight of additional FSP resources for artwork management • Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities. • Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs. • Support the development and maintenance of country regional text lists (cRTL). • Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries. • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes. • Support continuous improvement initiatives related to artwork review processes and labeling systems.

Role Description This is a remote position. We are excited to announce an opportunity for a talented and experienced professional to join our team as a Consultant/Biologics. Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this individual contributor role: Responsibilities: - Provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, with a focus on biologics development, manufacturing, and regulatory affairs. - Collaborate closely with clients to understand their needs, challenges, and objectives, and develop tailored solutions to address specific business and regulatory requirements. - Conduct assessments and gap analyses of clients' biologics programs, processes, and operations to identify areas for improvement and optimization. - Develop and implement strategic plans and initiatives to support clients' biologics development and commercialization efforts, including regulatory strategy, CMC (Chemistry, Manufacturing, and Controls) strategy, and lifecycle management. - Provide guidance and support on regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements. - Review and interpret regulatory guidelines, requirements, and industry best practices related to biologics development, manufacturing, and compliance. - Support clients in preparing for regulatory interactions and inspections, including FDA meetings, regulatory agency audits, and responses to regulatory inquiries. - Stay abreast of emerging trends, advancements, and regulatory changes in the biologics industry and provide insights and recommendations to clients. Qualifications - Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline, preferably in biochemistry, biotechnology, pharmaceutical sciences, or related field. - Minimum of 5 years of experience in the biopharmaceutical industry, with a focus on biologics development, manufacturing, or regulatory affairs. - Strong expertise in biologics development and manufacturing processes, including upstream and downstream processing, analytical methods, and characterization techniques. - Deep understanding of global regulatory requirements and guidelines applicable to biologic products, including FDA, EMA, and ICH regulations. - Proven track record of successful consulting engagements or project management in the biopharmaceutical industry, with demonstrated ability to deliver results and drive client satisfaction. - Excellent communication and interpersonal skills, with the ability to effectively engage with clients at all levels of the organization. - Strong analytical and problem-solving abilities, with the ability to assess complex challenges and develop innovative solutions. - Willingness to travel as needed to meet client requirements. Benefits - Competitive compensation packages are available. - Be part of our network of Subject Matter Experts. EEO Employer Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com . Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality. Follow us on LinkedIn for more company updates and opportunities.