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Director, Regulatory Affairs, CMC
10 hours ago
This position reports to the Senior Director, Regulatory Affairs, CMC and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. For Boston based candidates, this is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
Propose and implement global CMC regulatory strategies and provide regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management, with potential focus on late stage/commercial programs.
Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner.
Assess and communicate regulatory requirements to ensure all CMC activities are in compliance with applicable regulations and guidelines.
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of high-quality CMC sections of regulatory submissions to support initial INDs/CTAs, marketing applications, supplements and variations.
Work closely with Technical Writers to ensure CMC sections of regulatory submissions are accurate and compliant.
Lead multidisciplinary teams preparing responses to Regulatory Agency questions.
Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions for initial INDs/CTAs, marketing registration applications, supplements and variations.
Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of regulatory applications.
Provide regulatory support for relevant quality systems such as change control, deviation t, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
Develop, review, and maintain Regulatory CMC departmental policies and SOPs.
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs.
Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company's Human Resource policies and practices.
Some travel may be required.
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Other duties as assigned.
QUALIFICATIONS:
A Bachelor's, Master's, or PhD in a scientific, medical, or regulatory discipline and 10+ years of management experience or combination of degrees and experience of progressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environment required.
Experience in managing commercial programs marketed in US, EU, Canada and other major markets
Experience in rare disease indications and/or orphan drug development is desirable.
Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations in US and other major markets.
Demonstrated track record of successful global regulatory submissions and strategies.
Prior Regulatory Agency liaison experience is desirable.
Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
Detail oriented with excellent written and verbal communication and presentation skills.
Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members.
Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.
Experience with Veeva RIM is desirable.
The base salary range for this role is $224,600 to $248,400 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
