Manager/Associate Director, Regulatory Affairs CMC

Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios?  If so, this Manager/Associate Director, Regulatory Affairs CMC could be an ideal opportunity to explore.

As a Manager/Associate Director, Regulatory Affairs CMC you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements.  Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies. 

• Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate.  Provides strategic direction, data assessment and conclusions within and across departments.   Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation   

• Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).  

• May deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs). 

• Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications.   

• Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply.  Ensures information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.

• Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work

• Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company. 

• Operates with considerable independence, except for matters that affect corporate or agency policies.  Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.  

• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s Degree in Life Sciences or associated discipline
• Experience in drug development and manufacturing and supply processes and may have a specialized area of expertise. 
• Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. 
• Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development.)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD in Life Sciences or associated discipline
• Pharmaceutical and/or vaccines product development
• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership 
• Continued professional growth in global regulatory affairs including communication of evolving/emergi