Senior Regulatory CMC Manager for Antisense Oligonucleotides
1 month ago
Overview of the Position
This position entails delivering specialized Regulatory CMC knowledge to shape and execute the global regulatory framework, operations, and strategic planning for the CMC components of designated projects/products. Key responsibilities include the formulation and assembly of submissions/documentation for specific small molecule initiatives, collaborating closely with the Regulatory CMC Lead and essential stakeholders. The role serves as the primary liaison for affiliates regarding Regulatory CMC matters in the assigned territories and oversees routine and exceptional interactions with Health Authorities as assigned. Depending on the developmental phase and intricacy of the program, this role may function as the Regulatory CMC Lead for early-stage projects or collaborate with the Regulatory CMC Lead for later-stage or commercial initiatives. The Regulatory CMC Lead acts as the principal global contact for Regulatory CMC activities linked to the program and reports to the Regulatory CMC Antisense Oligonucleotide (ASO) Team Lead.
The ideal candidate must demonstrate proven leadership capabilities and the ability to work collaboratively across various functions and cultures. Exceptional communication skills, along with comprehensive knowledge of Regulatory CMC for small molecules or ASOs, are essential.
Responsibilities
- Deliver strategic and operational Regulatory CMC expertise while supporting cross-functional teams as needed, adapting flexibly within and across regions to provide extensive operational assistance to achieve project/products and business goals.
- Develop and implement CMC Regulatory operational strategies for products, aiding in the preparation and submission of regulatory documents (including IND/IMPD/CTAs/MAAs).
- Oversee submissions from content definition to leading reviews to ensure thorough, clear, and precise submissions to Health Authorities.
- Author and/or review regional and global CMC submission documents and responses to inquiries from Health Authorities.
- Manage CMC elements of routine and exceptional Health Authority interactions, including issue resolution and negotiation of approvals, as assigned.
- Stay informed about changes in the Regulatory CMC landscape to provide guidance to key stakeholders and teams.
- Contribute to Regulatory CMC risk assessments and mitigation strategies, ensuring alignment with the overall global Regulatory CMC framework.
- Coordinate and finalize regulatory evaluations of CMC modifications within designated systems.
- Assume responsibilities from the Team Lead or Global Regulatory CMC lead as agreed, maintaining transparent communication regarding the status and issues related to submissions.
- Lead or assist in executing project assignments that support business objectives, such as representing Regulatory CMC in cross-functional workstreams.
- Lead or assist in the execution of Regulatory CMC initiatives and the establishment of Regulatory CMC standards and SOPs, as assigned.
- Ensure proper documentation is maintained in the designated system for submissions.
Key Contacts and Interactions: Engages ethically with various international, cross-functional departments, industry peers, and health authority representatives at all levels.
Customer Focus: Collaborates with key stakeholders in functional areas both internally and externally, including subject matter experts, partners, and regulatory agency personnel.
Qualifications
Regulatory Expertise
- Extensive relevant experience in the pharmaceutical sector or a regulatory authority CMC review role, with a focus on Regulatory CMC and preferably experience in pharmaceutical manufacturing, analytical development, or quality assurance/control.
- Proven success in authoring and contributing to CMC submission documents for development and/or marketed products (biological, oligonucleotide, and/or chemical entities).
- Comprehensive registration experience acquired from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products.
- Experience in direct communication and negotiation with regulatory agencies regarding CMC issues.
- Knowledge of GMP standards and standard systems (e.g., change management systems).
- Demonstrated capability in leading cross-functional teams and operating within a matrix organizational framework.
Leadership and Management Skills
- Ability to work independently and collaboratively within project teams or committees to achieve group objectives and key project milestones.
- Capacity to influence cross-functional stakeholders to ensure the execution of optimal Regulatory CMC strategies.
- Demonstrated inclusive leadership and emotional intelligence, along with effective verbal and written communication skills in remote working environments.
- Proven strategic thinking, change leadership, and risk assessment abilities, including the capacity to integrate overall business objectives into departmental goals and effectively communicate these.
- Demonstrated competency in operations, planning, project management, and tracking complex projects with clearly defined critical paths.
- Proven ability to manage projects across global locations and time zones, fostering strong, productive working relationships in a diverse cultural setting.
- Enthusiastic approach to teamwork, working inclusively and collaboratively with others both internally and externally. Strong conflict resolution skills with a proven ability to reach satisfactory resolutions among all parties involved.
Preferred/Additional: Recognized experience in project and timeline management is desirable but not essential.
Education: Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; a graduate degree is preferred.
Additional Information
Why Biogen?
We are a global team dedicated to excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established organization while fostering an environment where individual contributions are valued. Our team comprises some of the most talented and passionate professionals who have unparalleled opportunities for learning, growth, and skill enhancement. Above all, we collaborate to deliver transformative medicines, with every role being crucial to our mission. We are committed to building a culture of inclusion and belonging that reflects the communities we serve and the patients we support. We recognize that diverse backgrounds, cultures, and perspectives enhance our strength and innovation, and we are focused on creating teams where every employee feels empowered and inspired.
-
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full timeOverview of the Position This position is pivotal in delivering Regulatory CMC expertise to shape and execute the global regulatory framework, operations, and planning concerning the CMC components of designated projects/products. Key responsibilities encompass the preparation and assembly of submissions/documentation for specific small molecule...
-
Senior Regulatory Affairs Manager
3 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full timeJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at AbbVie. As a key member of our Regulatory Affairs department, you will be responsible for implementing regulatory strategies and deliverables for a portfolio of early/late development or marketed products for the Europe Area Regulatory Affairs (ERA).Key...
-
Regulatory Project Manager and Filing Expert
16 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Full timeRegulatory Project Manager and Filing Excellence RoleProclinical is seeking a dedicated and experienced Regulatory Project Manager and Filing Excellence Consultant to join our team. This role will focus on developing and implementing best practices for preparing major global regulatory filings.Key Responsibilities:Project management for late-stage global...
-
Regulatory Project Manager and Filing Expert
20 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Full timeRegulatory Project Manager and Filing Excellence RoleProclinical is seeking a dedicated and experienced Regulatory Project Manager and Filing Excellence Consultant to join our team. This role will focus on developing and implementing best practices for preparing major global regulatory filings.Key Responsibilities:Project management for late-stage global...
-
Regulatory Affairs Deputy Manager
6 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewDeputy Regulatory Affairs ManagerSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team.Key ResponsibilitiesAs a Deputy Regulatory Affairs Manager, you will be responsible for:Collecting, organizing, and tracking documentation required for Marketing Authorisation applications and responses to...
-
Regulatory Affairs Deputy Manager
6 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewDeputy Regulatory Affairs ManagerSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team.Key ResponsibilitiesAs a Deputy Regulatory Affairs Manager, you will be responsible for:Collecting, organizing, and tracking documentation required for Marketing Authorisation applications and responses to...
-
Regulatory Affairs Deputy Manager
1 day ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Title: Deputy Regulatory Affairs ManagerAbout the RoleSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring the compliance of our marketing authorisation applications.Key ResponsibilitiesCollect, organise, and...
-
Regulatory Affairs Deputy Manager
1 day ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Title: Deputy Regulatory Affairs ManagerAbout the RoleSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring the compliance of our marketing authorisation applications.Key ResponsibilitiesCollect, organise, and...
-
Regulatory Affairs Deputy Manager
5 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewDeputy Regulatory Affairs ManagerSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team.Key ResponsibilitiesThe successful candidate will be responsible for:Collecting, organizing, and tracking documentation required for Marketing Authorisation applications and responses to questions in eCTD...
-
Regulatory Affairs Deputy Manager
5 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewDeputy Regulatory Affairs ManagerSelect Pharma Limited is seeking a highly skilled Deputy Regulatory Affairs Manager to join our team.Key ResponsibilitiesThe successful candidate will be responsible for:Collecting, organizing, and tracking documentation required for Marketing Authorisation applications and responses to questions in eCTD...
-
Deputy Compliance Manager
3 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob SummaryWe are seeking a highly skilled Deputy Compliance Manager to join our Regulatory Affairs team at Select Pharma Limited. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our marketing authorisation submissions.Key ResponsibilitiesDocument Management: Collect,...
-
Regulatory Affairs Director
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Description**Regulatory Affairs Manager**We are seeking an experienced Regulatory Affairs Manager to join our team at Select Pharma Limited. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the approval of submissions.Key Responsibilities:Post-approval...
-
Regulatory Affairs Director
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Description**Regulatory Affairs Manager**We are seeking an experienced Regulatory Affairs Manager to join our team at Select Pharma Limited. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the approval of submissions.Key Responsibilities:Post-approval...
-
Regulatory Affairs Specialist
1 day ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewSelect Pharma Limited is seeking an experienced Regulatory Affairs Manager to join our team in a growing generic pharmaceutical company.The successful candidate will be responsible for post-approval and compliance activities, working closely with the pre-approval team to ensure seamless execution.Key Responsibilities:Execute post-approval and...
-
Regulatory Affairs Specialist
1 day ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewSelect Pharma Limited is seeking an experienced Regulatory Affairs Manager to join our team in a growing generic pharmaceutical company.The successful candidate will be responsible for post-approval and compliance activities, working closely with the pre-approval team to ensure seamless execution.Key Responsibilities:Execute post-approval and...
-
Regulatory Affairs Specialist
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewSelect Pharma Limited is seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and supporting the development of our generic pharmaceutical portfolio.Key Responsibilities:Post-approval and compliance activities, with...
-
Regulatory Affairs Specialist
4 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob OverviewSelect Pharma Limited is seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and supporting the development of our generic pharmaceutical portfolio.Key Responsibilities:Post-approval and compliance activities, with...
-
Regulatory Affairs Specialist
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Description**Regulatory Affairs Officer**We are seeking an experienced and enthusiastic Regulatory Affairs professional to join our growing team at Select Pharma Limited. This exciting opportunity will provide the successful candidate with exposure to various aspects of Regulatory compliance and the chance to supervise and guide a team.Key...
-
Regulatory Affairs Specialist
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob Description**Regulatory Affairs Officer**We are seeking an experienced and enthusiastic Regulatory Affairs professional to join our growing team at Select Pharma Limited. This exciting opportunity will provide the successful candidate with exposure to various aspects of Regulatory compliance and the chance to supervise and guide a team.Key...
-
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full timeAbout This RoleWe are seeking a highly motivated and detail-oriented Senior Associate II, Drug Safety, PV Regulatory Intelligence to join our team. As a key member of our Reporting & Submissions team, you will play a critical role in facilitating the ongoing management of Pharmacovigilance (PV) operations for Biogen Partners International Partner Markets...
