Regulatory Affairs Manager III
Associate Director, Biosimilars, Regulatory CMC
The Global Regulatory CMC Early Development Lead, Gene Therapy is responsible for the line management of the team members reporting into him/her, with responsibilities for early stage of development activities for the gene therapy products portfolio. The Global Regulatory CMC Development Lead assigns projects to the team members, supports the team members in setting regulatory CMC strategies and their daily work. He/she ensures coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities. The Global Regulatory CMC Development Lead also acts as Global Reg CMC Lead for assigned programs as needed. This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development gene therapy programs.
Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific gene therapy programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.
The role is also responsible to support the evaluation of business development activities including due diligence.
The CMC GRL provides regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.
This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required. DUTIES & RESPONSIBILITIES:
1) Accountable for line management and development of direct reports.
2) Developing soft and technical skills, ensuring coaching and mentoring of the assigned team, and conduct performance assessment.
3) Managing team resources efficiently - ensure proper resources allocation, enhance knowledge sharing and support the team to prioritize activities.
4) Ensure the development of the Global RegCMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority interaction and influence).
5) Participate in technical and soft skill development, coaching, and performance feedback of the people working in Global RegCMC community, if requested by their management.
6) As part of Global RegCMC, participate in the development of working processes and activities to increase the efficiency within Global RegCMC function.
7) Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.
8) Ensures that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
9) Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
10) Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
11) Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
12) Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
13) Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
14) Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products.
15) Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.
16) Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.
17) Partners with regulatory regional leads for exchange of project/product related information and submission planning.
18) Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
19) Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs.
20) Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC LT as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.
21) Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
22) Represents Global RegCMC on due diligence and divestment teams as assigned by the Global RegCMC LT.
23) Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.
24) Participates in skill development and coaching of other Global RegCMC Team members as required.
25) Responsible for management, coaching and development of direct reports as applicable.
KEY CONTACTS & INTERACTIONS:
Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels. CUSTOMER FOCUSED:
Interacts with key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel. QUALIFICATIONS:
1) Regulatory Skills
- At least 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 7+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
- Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
- Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
- Knowledge of global guidance, regulations and ICH/GMP requirements
- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure 2) Leadership/Management Skills
- Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
- Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
- Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
- Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
- Competence in people development and management.
PREFEFRED/ADDITIONAL: Recognized experience in project and people management.
EDUCATION: BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred