Global Regulatory Affairs CMC Lead PSMA
Global Regulatory Affairs CMC Lead PSMA
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Salary Not Disclosed
1 Vacancy
Job Description
See Yourself at Telix
The Manager GRA CMC is responsible for managing CMC specific regulatory activities for the development and commercialization of pharmaceutical products. This role requires excellent understanding of technical (Quality/CMC) regulatory requirements guidance the ability to write technical Module 3 dossiers and effectively communicate with internal and external stakeholders. The Manager RA CMC will ensure that all global regulatory submissions have CMC dossiers that are highquality compliant and prepared in a timely manner across projects.
Key Accountabilities
- Regulatory Submissions: Plan prepare and review CMC Module 2.3 & Module 3 documents for INDs IMPDQs NDAs BLAs MAAs CTAs and postapproval supplements and variation submissions ensuring accuracy and completeness.
- Regulatory Compliance: Monitor and interpret global CMC regulatory requirements and guidelines such as ICH US FDA CFRs EMA Directives and Annexes ensuring that company practices and documentation are compliant with current regulations.
- CrossFunctional Collaboration: Collaborate with internal stakeholders including R&D Quality Assurance Manufacturing and Commercial teams to ensure alignment and support for regulatory strategies and submissions.
- Risk Management: Identify potential CMC regulatory risks and develop mitigation plans to proactively manage issues.
- Documentation and Systems: Ensure that regulatory CMC documentation is managed efficiently and that systems and processes are in place for the proper archiving and retrieval of regulatory documents.
- Regulatory Agency Interactions: Serve as the primary point of contact for CMC regulatory interactions with global health authorities preparing teams for meetings and leading discussions.
- Regulatory Intelligence:Stay current with evolving regulatory landscapes including new guidelines policies and trends and communicate key changes to relevant stakeholders.
Education and Experience:
- Bachelors degree required; Advanced degree (Ph.D. or equivalent) in Chemistry Biological Sciences Engineering or a related field preferred.
- 7 years of experience in Regulatory Affairs with a strong focus on CMC in the pharmaceutical or biotechnology industry.
- Regulatory Knowledge: Strong knowledge of global regulatory requirements and guidelines for CMC including ICH guidelines and FDA EMA and other health authority regulations.
- Communication Skills: Excellent technical writing and verbal communication skills with the ability to effectively communicate complex regulatory issues to internal and external stakeholders.
- Project Management: Strong project management skills with the ability to manage multiple projects and deadlines in a fastpaced environment.
- Analytical Skills: Strong analytical and problemsolving skills with the ability to assess and mitigate regulatory risks.
- Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies.
Key Capabilities:
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Resultsoriented: Driven to achieve goals and objectives with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment adjusting to changing priorities and take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels using clear and concise language
- Collaboration: Work effectively as part of a team actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development continually seeking opportunities to expand your knowledge and skills
Required Experience:
Exec
Employment Type
Full Time
