Senior Manager, Regulatory Affairs

Akero Therapeutics; Poland; Remote; PLN 617,000 - 745,000; Full time

Job summary

A biotechnology company is seeking a Senior Manager for Regulatory Affairs to lead the preparation and submission of documents to Health Authorities. The role requires managing regulatory systems and collaborating with cross-functional teams to enhance regulatory strategies. Candidates should have 8-12 years of experience in the pharmaceutical or biotech sectors, a scientific degree, and proven project management skills. Compensation ranges from $170,000 to $205,000 annually, adjusted for geography.

Qualifications

• 8-12 years regulatory experience in pharmaceutical or biotech industries.
• Experience with INDs, CTAs, NDAs, BLAs.
• Strong negotiating and conflict resolution skills.

Responsibilities

• Lead project teams in the preparation of high-quality regulatory documents.
• Manage submissions to Health Authorities, ensuring compliance.
• Promote continuous improvement in Regulatory Affairs capabilities.

Skills

Leadership in regulatory submissions

Strong analytical skills

Excellent communication skills

Regulatory project management

Negotiation skills

Education

Bachelor’s degree in a scientific discipline

Postgraduate qualifications (MS, PharmD, PhD, PMP, MBA)

Tools

Veeva Vault

MS Office Suite

eCTD and ESG requirements knowledge

Job description

Job Summary

The Regulatory Affairs (RA) Senior Manager works collaboratively with the RA Director and other cross-functional team leaders and is responsible for managing the US IND and oversight of regulatory information management (RIM) systems. The responsibilities include thorough preparation and completion of global regulatory submissions and active management of regulatory systems throughout the product lifecycle for EFX. This role will also involve projects that continuously improve or advance RA capabilities.

Job Responsibilities

• Leads project teams and actively participates in the development and writing of high-quality regulatory documents
  • Independently authors regulatory documents and reviews documents for submission readiness to Health Authorities (HAs), including IND / CTA / BLA submissions (e.g., general correspondence, information amendments, protocol amendments [protocols, CSRs, IB, investigator information updates, meeting requests/packages, periodic/safety reports])
  • Ensures work complies with established processes, templates, policies, and applicable regulatory guidance
  • Ensures supporting data are identified, obtained, and that rationales and company position are clearly and accurately presented
• Oversees and guides the preparation, compilation, and timely completion of regulatory submissions within designated local regions
  • Collaborates with regulatory counterparts, cross-functional contributors, and submission teams to resolve comments, address regional requirements, and drive alignment
  • Advances document review and approval stages of both internal and external outsourced regulatory activities, interacting with relevant stakeholders as necessary
  • Enhances delivery of Akero’s regulatory objectives by building effective internal and external relationships
• Manages Veeva Regulatory Information Management (RIM) and internal Akero systems
  • Partners with RA Director to conduct end-to-end administration of Veeva RIM, including document workflow management, submission compilation, correspondence/submission archiving, metadata entry, change control configuration, release update management, user access, and application/submission tracking
  • Archives and tracks Health Authority correspondence, queries, commitments, and other deliverables throughout the program lifecycle
• Facilitates regulatory team meetings and ensures effective conduct and follow-through
  • Participates in regulatory team meetings and is recognized as a knowledgeable resource for Regulatory Affairs in other departments
• Monitors regulatory intelligence, identifies/optimizes process improvement, and assists in the authoring/updating of SOPs
  • Understands the regulatory environment to leverage internal knowledge and monitors external regulatory intelligence to perform impact assessments on the development program
  • Contributes to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities

Qualifications

Education and Experience

• Bachelor’s degree in a scientific discipline; additional/postgraduate qualifications (MS, PharmD, PhD, PMP, MBA) are advantageous
• 8-12 years regulatory experience within the pharmaceutical or biotech industries; experience managing projects with remote teams and through external alliances preferred
• Title will be commensurate with experience

Regulatory Affairs Experience

• Led or filed applications, including but not limited to INDs, CTAs, NDAs, BLAs, MAAs, or equivalents
• Proven track record of successfully managing and delivering regulatory projects in early to late stage (Phase 2-3) development
• In-depth knowledge of relevant Health Authorities (HA), evidenced by past effectiveness and success with HA interactions
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, HA negotiations, and responses
• Ability to interpret HA policies and guidance and apply them as appropriate in product development and labeling regulatory activities for pharmaceutical products

Industry Experience

• Keeps current on global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables
• Previous experience with emerging markets and/or therapeutic areas with limited precedent is advantageous but not essential
• Knowledge of Regulatory Affairs discipline throughout the product lifecycle
• Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical products
• Prior experience overseeing Contract Research Organizations and external vendors
• Strong analytical skills, attention to detail, organizational and writing skills as evidenced in past roles
• Proactive, hands-on attitude in fast-moving, matrixed environments
• Adaptable team player comfortable with ambiguity
• Agile learner, able to move between detail and project strategy
• Strong interpersonal and communication skills with ability to rapidly adapt to different team dynamics
• Strong negotiation and conflict resolution skills
• Ability to build strong relationships and lead by influence

Technical skills

• Understanding and working knowledge of 21 CFR Part 11 compliant internal electronic systems for planning, preparing, tracking and archiving submissions to HAs
• Working knowledge of eCTD and ESG requirements
• Experience with Veeva Vault is strongly preferred
• Strong organizational and project management skills (MS Office Suite, Veeva RIM, SharePoint, Smartsheet)
• Excellent project integration, planning, communication, and documentation skills. Familiarity with planning tools (MS Project, Smartsheet, Excel, PowerPoint, Outlook)

Compensation

Pay range: $170,000 - $205,000 per annum. The compensation range is for the San Francisco Bay Area, California and may be adjusted for other geographic areas.