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Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing
3 meses atrás
The Position
Reporting to the CMC Senior Principal Scientist, International CMC (LATAM), the successful Associate Principal Scientist will be accountable for managing/supporting regional CMC regulatory activities for Biologic and Biosimilar new product registrations and subsequent lifecycle activities. This may involve assessment of business development opportunities, regulatory & submission strategy, development of regional CMC strategy in Latin America, preparation of CMC documentation and execution of regional post-approval CMC change management and new product registrations for Organon’s portfolio of biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.
They will work closely with CMC Product Leads to ensure that key CMC projects are successfully prosecuted in the region.
Responsibilities
Bring energy, knowledge, innovation, and leadership to carry out the following:
- For assigned product portfolio, develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice, and post-approval changes, as appropriate.
- Working collaboratively with Global CMC Regulatory Affairs Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the products lifecycle.
- Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
- Boost Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
- Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for LATAM markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to promote right first-time submissions.
- Ensure high quality and timely responses to Regulatory Agency questions in LATAM markets and fulfilment of regulatory commitments to Regulatory Agency deadlines.
- Sponsor product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
- Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
- Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.
Required Education, Experience and Skills
- Must have a bachelor’s or master’s degree in chemistry, pharmacy, biology or a related science, with at least 7 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory OR advanced degree with at least 4 years overall relevant experience.
- At least four years’ experience in CMC Regulatory Affairs for biologic or biosimilar products.
- Experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for biologic/biosimilar products, development, manufacturing and/or quality assurance. Experience with new product applications would be an advantage.
- Direct Health Authority experience would be an advantage.
- Demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Proven ability to convey effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English.
- Ability to influence and work both freely and collaboratively in a team structure.
- Proven ability to work well under pressure.
