Senior CMC Regulatory Affairs Manager

Arlesheim - Switzerland

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Alentis Therapeutics the Claudin-1 Company is on a mission to treat cancer and reverse fibrosis. To this end we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney liver and lung fibrosis.

Tasks

The Senior CMC Regulatory Affairs Manager is responsible for defining leading and executing the CMC regulatory strategy preparing the regulatory dossiers and supporting worldwide submission activities for Alentis pipeline products including monoclonal antibodies and antibody-drug conjugates. The candidate will be responsible for ensuring compliance with global regulatory requirements and provides insights to guide Alentis programs through standard and accelerated regulatory pathways from IND to BLA. The candidate serves as a CMC regulatory representative within internal cross-functional teams and in regulatory agencies interactions.

Your tasks:

Develop implement and execute the CMC regulatory strategy for Alentis pipeline products from IND/CTA clinical stage through BLA/MAA and post-marketing maintenance
Author review and prepare for submission CMC sections of regulatory dossiers including for briefing packages INDs IMPDs BLAs/MAAs
Lead and coordinate internal review processes to ensure timely delivery of CMC regulatory documentation
Participate in cross-functional meetings and collaborate closely with key stakeholders to ensure compliance and alignment with development timelines and deliverables
Support cross-functional teams in devising CMC regulatory strategy including accelerated pathways
Address CMC/Quality related requests for information from Health Authorities (FDA EMA etc.) according to required deadlines
Track post-approval CMC commitments assess the regulatory impact and ensure implementation of the required changes
Assess and proactively escalate CMC regulatory risks and propose appropriate mitigation strategies
Support due diligence activities and inspections/audits related to CMC regulatory aspects
Monitor evolving global CMC regulatory requirements for biologics including monoclonal antibodies and antibody-drug conjugates

Requirements

PhD Degree in Life Sciences Biotechnology Pharmacy Pharmaceutical Sciences Chemistry or a related field
8 years of hands-on experience managing CMC regulatory submission preparation in EU and US for biologics preferably including monoclonal antibodies and antibody-drug conjugates
Strong knowledge of ICH guidelines FDA EMA and other international regulatory requirements
Excellent written and oral communication skills with proven leadership and project management abilities
High attention to detail and strong organizational skills
Fluency in English
Ability to handle multiple projects in parallel prioritise and balance workload to achieve business goals
Flexibility in responding to changing priorities
Experience with accelerated pathways is desirable
Proficient computer skills relevant to regulatory document preparation and project tracking
Strong experience reviewing scientific information assessing regulatory risk and presenting data clearly in oral and written communications
Proactive and able to work independently with strong problem-solving skills good interpersonal communication and multicultural awareness

Benefits

We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team please submit your CV.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil Switzerland with 2 days home office per week.

Tasks

Your tasks:

Develop implement and execute the CMC regulatory strategy for Alentis pipeline products from IND/CTA clinical stage through BLA/MAA and post-marketing maintenance
Author review and prepare for submission CMC sections of regulatory dossiers including for briefing packages INDs IMPDs BLAs/MAAs
Lead and coordinate internal review processes to ensure timely delivery of CMC regulatory documentation
Participate in cross-functional meetings and collaborate closely with key stakeholders to ensure compliance and alignment with development timelines and deliverables
Support cross-functional teams in devising CMC regulatory strategy including accelerated pathways
Address CMC/Quality related requests for information from Health Authorities (FDA EMA etc.) according to required deadlines
Track post-approval CMC commitments assess the regulatory impact and ensure implementation of the required changes
Assess and proactively escalate CMC regulatory risks and propose appropriate mitigation strategies
Support due diligence activities and inspections/audits related to CMC regulatory aspects
Monitor evolving global CMC regulatory requirements for biologics including monoclonal antibodies and antibody-drug conjugates

Requirements

PhD Degree in Life Sciences Biotechnology Pharmacy Pharmaceutical Sciences Chemistry or a related field
8 years of hands-on experience managing CMC regulatory submission preparation in EU and US for biologics preferably including monoclonal antibodies and antibody-drug conjugates
Strong knowledge of ICH guidelines FDA EMA and other international regulatory requirements
Excellent written and oral communication skills with proven leadership and project management abilities
High attention to detail and strong organizational skills
Fluency in English
Ability to handle multiple projects in parallel prioritise and balance workload to achieve business goals
Flexibility in responding to changing priorities
Experience with accelerated pathways is desirable
Proficient computer skills relevant to regulatory document preparation and project tracking
Strong experience reviewing scientific information assessing regulatory risk and presenting data clearly in oral and written communications
Proactive and able to work independently with strong problem-solving skills good interpersonal communication and multicultural awareness

Benefits

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil Switzerland with 2 days home office per week.