Senior Director-Regulatory SPM & CMC

Pharmalex, a Cencora company are seeking a Senior Director, Regulatory Affairs for Strategy and Procedure Management (SPM) and CMC.

This role is to be remote based in the US and will have 6, US based direct reports.

The key responsibilities as Regulatory Affairs Senior Director include:

• Provide a wide range of flexible services within regulatory affairs, includes providing strategic input and navigating clients through the processes in addition to the hands-on activities required to prepare and submit documentation.

• Responsible for driving major new REG programs in close collaboration with client partners and PAL, including responsibility for implementation and continuous improvement of budget, KPIs and other project management tasks.

• Thought leadership in relevant technical areas of REG specialism.

• Develop and maintain strong client relationships and proactively seek opportunities for increased service support.

• Participation in, and provision of strategic leadership of, regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.

• Preparation, review and compilation of documents within the framework of regulatory affairs projects.

• Communication with clients and Health Authorities.

• Responsible for scientific advice procedures and representation of clients with health authorities.

• Responsible for the planning and execution of client projects in accordance with KPIs. Leadership and strategic guidance of project teams with colleagues and qualified external partners.

• Providing Regulatory Strategy and Procedure Management thought leadership to a variety of regulatory programs and projects.

• Active participation in staffing proposals and decisions for projects.

• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. As appropriate, shape future policies through thought leadership and participation in external bodies.

• Presenting seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise.

• Support the PAL in designing, communicating, implementing and optimizing the PA strategy. Representation of departmental interests towards the PAL and Head of VDC REG.

• In partnership with the PAL lead on operational steering of and definition of processes within the PA.

• Comply with, maintain and take accountability for optimizing internal processes.

• Creation of a motivational working environment. Technical support and coaching of colleagues.

• Formation of the leadership culture within the department in close cooperation with the PAL.

• Leadership for acquisition of new clients/projects (proposal coordination, participation in bid defense meetings, etc.)

• Lead VDC led commercial, marketing and business development activities including proposal input & management.

• Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.

• In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.

Experience and Educational requirements:

• Extensive professional experience in industry or area of responsibility; good network across industry and associations; in-depth understanding of pharmaceutical industry market trends regarding own technical area of expertise; complementary knowledge and expertise incl. financial & business acumen; solution focus driving resolution of complex problems.

• University degree in Life Science.

Minimum skills and knowledge requirements:

• Leadership and critique to drive definition of GCS's strategic goals as well as strategic goals of partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects); ability to balance client requests and company interests.

• Thought leader when defining ways of working across the business. Ability to adjust rapidly to new, unknown, challenging situations and coach others through the change; full discretion to drive strategy and take action consistent with operating policies.

• Drives extensive business process reengineering activities and provides consultation related to change management. Proactively leads on up/cross selling opportunities. Ability to analyze and solve problems and to develop pragmatic solutions at a higher level (e.g. company level).

• Extensive experience and proven strength in leading, mentoring, managing and motivation of staff.

• Ability to lead large international and/or complex project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according to project milestones, convincing others in difficult change management situations.

• Ability to manage client relationships at all levels including C-suite, ability to convey strategic goals of collaboration.

• Excellent communication and negotiation skills (written and verbally), proven capability to communicate critical issues and proposed solutions to senior management levels; ability to convey stakeholders even in critical or sensitive situations. Excellent skills in presentation; convincing and confident appearance.

• English business fluent.

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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