The Opportunity:
Reporting to the Associate Director, Regulatory Affairs & Pharmacovigilance of our Mexico sales affiliate, as the Local Regulatory Responsible (LRR) Mexico, Region LATAM & Partner Business, you will focus on local regulatory requirements and Health Authority national engagements. You will be responsible for new product registration, product lifecycle maintenance (variations, renewals), obtaining import licenses and local product batch release. You will also manage the evaluation of advertising materials and mainly focus on biological, biotechnological, and orphan drug products.
This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid
The Role:
Regulatory Activities:
- 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.
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations.
- Plan, coordinate, track and communicate effectively local requirements and submission deadlines.
- Registration projects for CSL Behring products according to Company priorities.
- License maintenance, prepare, submit, and follow up variations and renewals for all CSL Behring products.
- Labelling, ensure country specific labelling requirements are fulfilled.
- Coordinate, review, and approve art works for the implementation of packaging materials.
- Simplified local batch release process and GMP inspection request.
- Obtain local batch release for biological products.
- Keep update importing licenses for all CSL Behring products.
- Evaluate and submit promotional materials to ensure compliance with local regulations.
- Maintain up to date global and local databases of regulatory submissions.
- Regulatory support for product inclusion in different institutions and for tender participation.
Your Skills & Abilities:
- Bachelor’s, Master’s, or equivalent degree in life-sciences (Pharmacy, QFB, QFI, IF).
- 5+ years of professional experience in local regulatory affairs , i.e., comprehensive understanding of local regulatory requirements, guidelines, and processes.
- Desirable experience in biotechnological, biological, and orphan drugs products.
- Expertise in local health authority systems i.e., DIGIPRIS, VUCEM.
- Expert MS Office skills.
- Desirable experience in regulatory systems i.e., Veeva, TrackWise, GLAMS
- 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; proven experience in managing e.g., regulatory submissions, timelines, and cross-functional teams (Commercial, Quality, Medical, Supply) to ensure timely and successful product registrations and compliance.
- Excellent organizational, time management and interpersonal skills in a global environment.
- Proven ability to work effectively both independently and in a team.
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.
