The Opportunity:
Reporting to the Associate Director, Regulatory Affairs & Pharmacovigilance of our Mexico sales affiliate, as the Specialist, GRA, LRR Mexico, Region LATAM & Partner Business, you will focus on local regulatory requirements and Health Authority national engagements. Your key interactions will be with local external stakeholders, e.g., Health Authorities, local industry association(s), in-market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA (Global Regulatory Affairs) regions.
This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid
The Role:
Strategy (execution) and management
- Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities; monitor and report progress consistently to stakeholders.
- Ensure strict compliance with local regulations, actively participating in policy activities with industry groups and trade associations. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions.
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulation and subsequently communicate requirements to GRA and local staff; participate actively in regulatory meetings, forums, and conferences to stay informed share insights and best practices within the organization.
RA support and stakeholder engagement
- Act as primary interface with local HAs, industry groups, and trade associations, representing the company's regulatory interests and fostering positive relationships; lead in-country regulatory processes, acting as the final contact point with HAs for licenses, partner regulatory licenses, and market access collaborations.
- Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation.
- Provide critical support for implementation of local legislation , promotional material review, interpretation of regulations and regulatory agency expectations as well as lead regulatory strategies for product launches and integrations at affiliate level.
- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs; monitor status of submitted regulatory activities with local health authorities.
- Act as primary RA representative for local ComOps: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.
- Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track.
- Ensure compliant labeling (SmpC, PIL, packaging) and manage timely updates including translation, and promotional material review.
Your Skills & Abilities:
- 3 to 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes.
- In-depth expertise on local health authority management.
- Required fluency in Spanish and English, oral and written, to include the ability to read and write emails and communicate effectively with global colleagues.
- Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance.
- Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximize impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives.
- Experience in successfully dealing with rapid change.
- Expert MS Office skills.
- Excellent organizational, time management and interpersonal skills in a global environment.
- Ability to work successfully in a complex global matrix organization.
- Proven ability to work effectively both independently and in a team.
- The expertise, determination and courage to resolve or escalate issues as appropriate.
- subject matter expert in job area typically obtained through advanced education and work experience.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
