Manager Cross-Regional Regulatory Affairs - Fixed Term (12 months)

Health Authority and Operating Company Interactions

Basic understanding of worldwide health authorities and applicability of procedures to the regions

• Participates in the preparation for meetings with regulatory agencies in the regions.
• Liaises directly with Operating Companies, as needed, to support submissions to HA’s.

Submissions

• Responsible for the preparation and provides review and input on global, regional, and local documents for submission to Health Authorities in the regions.
• Responsible for the preparation of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies. 
• Works with the Regional Regulatory Leaders and GRT to develop regional marketing approval submission plans and timing.
• Manages and tracks country-specific requirements for local submission purposes (e.g.  legal and technical documents, RMP)
• Responsible for submission tactical planning and timelines, including submission plans for the products’ life cycle, and communicates to relevant groups.
• Ensures follow-up of regulatory dossier after submissions.
• Oversees management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
• Liaises with the Regional Regulatory Leaders to advise the GRT, and as needed, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions.  
• On behalf of the regions, provides strategic input to CTA dossier content, scope and timing
• Contributes to the management of product lifecycle submissions (e.g., PSURs )

Labeling

• Serves as member of the Labeling Working Group (LWG) to provide regional input on proposed CCDS & updates
• Oversees development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.

Regulatory Input into Other Functions

• Engages GRL, Regional Regulatory Leaders and selected LOC representatives to enable execution of regional strategies
• Secures global resource deployment (e.g., Med Writing, Safety, PhD, Supply Chain) to ensure implementation of regional strategies.
• Provides regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
   

Role within the Regional Regulatory Affairs organization

• Leverages TA, strategic, tactical, operational and procedural synergies and efficiencies across regions.
• Facilitates interactions between regional and global functions where needed.
• Analyses regional & HA feedback to foster adaptive learning. 
• Tracks progress for assigned projects and generates reports for management as required
• Fosters and maintains ongoing communication and alignment with key stakeholders and business partners, including GRT, operational teams, regional teams and LOCs.
• As a member of the Regional Strategic Implementation Group participates in setting of operational direction 
• Actively participates in other management and leadership activities 
• Actively participates or provides leadership for process development or process improvement.

People Relationships

• Enhances engagement with regional teams through close proximity to R&D centers and global operational teams
• Facilitates management with regional/global teams (as needed)
• Coaches and mentors junior staff
• Has cross-regional and cross-functional leadership responsibility

Qualifications / Requirements

• Bachelor’s degree in a scientific field.
• 2–3+ years of Regulatory Affairs experience, including preparation and coordination of regulatory submissions.
• Experience with LATAM regulatory requirements and country-specific submission requirements.
• Previous experience in Medical Devices or Pharmaceutical industry.
• Advanced English, with strong verbal and written communication skills for interaction with global teams.
• Strong cross-functional collaboration and influencing skills, with the ability to lead initiatives without direct authority.
• Experience with EMEA and/or Asia-Pacific regulatory requirements is a plus.
• Experience with data analytics is a plus.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility