Job Description

This role is responsible for oversight of CMC regulatory strategies and operations during development and lifecycle of marketed medical devices, combination products and digital devices, support for business needs, and patient supply of internationally approved or to be approved products of multiple modalities. This candidate must have proven leadership and abilities to work cross-functionally and across regions.  Strong communication, negotiation and interpersonal skills are required.  The candidate will mentor and develop multiple direct and indirect reports. 

DUTIES AND RESPONSIBILITIES:

·       Provides strategic direction to Global and Regional Regulatory CMC Leads and global cross-functional teams to develop innovative regulatory CMC strategies supporting marketed product lifecycle management, business needs, and continuous supply to patients.

·       Ensures dossier compliance and quality, content, format, and timeliness of regulatory CMC supplemental applications and / or secure approvals in international markets

·       Collaborates with stakeholders to ensure dossier compliance and quality, content, format, and timeliness of regulatory CMC submissions and variations of Drug Device Combinations/Integral products

·       Provides regulatory CMC support for relevant Quality systems such as change control, deviation management, and inspection management.

·       Builds and maintains relationships/partnerships with relevant Biogen functions (e.g. Technical Development, Regulatory Affairs, Commercial, Supply Chain, Quality, asset management, affiliates, clinical, legal etc.) to allow for understanding of E2E processes and continuous improvements.

·       Provides Global and Regional Regulatory Leads and Asset Teams with leadership regarding Health Authority interactions, and management of critical regulatory issues, including Product recall, removal, correction or notifications.

·       Uses advanced knowledge of global regulations, guidelines, and expectations to interpret requirements of worldwide health authorities.

·       Practices smart risk-taking to apply new regulatory thinking and paradigms where possible.

·       Supports regulatory CMC vision and direction to add patient value and product differentiation.

·       Actively participates in and contributes to external relevant industry meetings, conferences, and forums including organizing, leading discussion, and delivering presentations.

·       Establishes relationships with major representative Health Authorities and trade association representatives to learn and to influence reflecting Biogen positions.

·       Develops meaningful metrics and reports for key regulatory CMC performance indicators (e.g. change control, change reportability, and submission creation, etc.).

·       Creates efficiency through transparent standardization, best practices, and activity out-sourcing; supports departmental business processes.

·       Provides information/input/reports to the Global Regulatory CMC Leadership Team as required.

KEY CONTACTS AND INTERACTIONS: Ethically interacts with multiple international, cross-functional departments, and industry peers at all levels. 

CUSTOMER FOCUSED: Interacts with a wide variety of outside contacts, including contractors, corporate partners, and regulatory agency personnel.

 POSITION IMPACT:

Affects other departments and/or corporate projects and ultimately compliance and quality of product submissions, facility registrations, and continued patient supply to multiple markets. Fulfillment of responsibilities supports attainment of team and/or departmental goals. Errors may result in delays to project timelines and product and site facility registration/compliance and product supply.

Qualifications

REGULATORY SKILLS

·       At least 15+ years industry experience in Medical Device Regulatory Affairs, manufacturing, quality, technical development, or a combination of the above, in the field.     10+ years international CMC regulatory experience required. Drug/Device Combination product, Digital Health, pharmaceutical or biotechnology experience is a distinct plus.

·       Previous direct experience in regulatory submission preparation.

·       Extensive experience with international health authority interactions.

·       Advanced knowledge and experience in interpretation of global regulations, guidelines, and expectations governing licensure and marketing of products in major regions (US/CAN, EEA, AP, MEA, LA).

·       Strong industry leadership and the ability to create opportunities to influence global thinking in relationship to Biogen viewpoints. 

LEADERSHIP/MANAGEMENT SKILLS

·       Demonstrated abilities to pioneer, coordinate, and work effectively with cross functional teams to attain group goals and key project milestones in alignment with business priorities.

·       Effective problem-solving skills and proven abilities to create solutions and prioritize multiple tasks.

·       Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.

·       Proven ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

·       Demonstrated strategic thinking and risk assessment with proven ability for optimism and energy in the face of change and adversity.

·       Proven ability to mentor, develop, and retain regulatory CMC professionals, including ability to motivate staff to perform at their top level, and to recruit skilled regulatory scientists.

·       Demonstrated abilities to drive results and to create and maintain a culture of excellence. 

EDUCATION:  Graduate degree in Life Sciences, Engineering, Biotechnology, Law or relevant Pharmaceutical Science preferred, however demonstrated appropriate experience is mandatory.

Additional Information

This role is responsible for oversight of CMC regulatory strategies and operations during development and lifecycle of marketed medical devices, combination products and digital devices, support for business needs, and patient supply of internationally approved or to be approved products of multiple modalities. This candidate must have proven leadership and abilities to work cross-functionally and across regions.  Strong communication, negotiation and interpersonal skills are required.  The candidate will mentor and develop multiple direct and indirect reports.