Reporting to the Regulatory Affairs, Pharmacovigilance Lead, as the Sr Manager, RPR (Regulatory Partner Responsible), LATAM Business Partner you will focus on partner management and oversight of partner activities. Your key interactions will be with Local partners, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA (Global Regulatory Affairs) Regional team.
This is a hybrid role, requiring three (3) days of onsite work weekly. #LI-hybrid
The Role:
Strategy (execution) & (partner) management
- Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly; conduct risk assessments of partners to identify potential risks and vulnerabilities.
Strategy (execution) & (partner) management
- Manage inventory of partners and ensure synergies are identified and implemented.
- Conduct periodic assessments and audits of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions.
- Act as point of contact for escalations and issue resolution related to partner activities.
- Align closely with GRA for contract management purposes to ensure regulatory standards are met.
Strategy (execution) & (partner) management
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations.
Strategy (execution) & (partner) management
- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs.
Strategy (execution) & (partner) management
- Act as primary RA representative for local ComOps: adopt a business perspective and explores opportunities, translates this thinking into actionable plans that fit with strategy.
Strategy (execution) & (partner) management
- Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track.
Internal stakeholder management and trainings
- Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs.
Internal stakeholder management and trainings
- Stay in close alignment with respective Head Partner Business to oversee partner-specific activities for ensuring timely and standardized delivery of goods and services.
- Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.
- Stay accountable for planning, leading and delivering complex regional strategies across broad range of CSL products, while ensuring alignment with company/commercial strategies.
Your Skills & Abilities:
- Relevant bachelor’s degree or equivalent secondary education in e.g., business administration, natural sciences (biology, chemistry or pharmacy), law or regulatory affairs.
- Advanced degree (Master’s or PhD) preferred in e.g., business administration, natural sciences (biology, chemistry or pharmacy), law or regulatory affairs.
- (Optional but desired) certifications in quality management and (ideally) vendor management, e.g., Certified Quality Auditor (CQA), Certified Manager of Quality (CMQ) or Certified Supplier Quality Professional (CSQP).
- 7+ years of experience in oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry.
- Required fluency in Spanish and English, oral and written, to include the ability to read and write emails and communicate effectively with global colleagues.
- Partner management experience: proven experience in managing relationships with third-party vendors, including e.g., logistics providers or service providers.
- Experience in managing commercial 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.
- Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive.
- 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.
