VP, Quality Assurance

  •  

Boston, MA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 68 days ago

  by    Sam Murphy

This job is no longer available.

We are seeking a Director/Sr. Director, Regulatory Affairs to join our team. This role proactively leads the development, planning and execution of global regulatory strategies with a focus on efficient, rapid and timely approvals while balancing the business needs with regulatory compliance. The main roles and responsibilities include, but are not limited to: represent Global Regulatory Affairs at the program level across the indication life cycle; provide oversight, direction and ensure consistency of global regulatory development strategies and alignment with department objectives and company goals; identify and develop solutions to emerging issues leading to resolution and appropriate internal and external communications; and maintain compliance with the companies policies, procedures, and global regulatory commitments. The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.

RESPONSIBILITIES:

  • Leads the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development for lead indications; provides proactive guidance to internal groups and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.
  • Creates and completes regional regulatory documents for various submissions, including but not limited to: clinical trial applications and their maintenance, amendments, and variations, and other relevant regulatory filings; directs business partners, internal staff members, and/or directly manages the preparation of forms, cover letters or other administrative components for regulatory submissions.
  • Ensures appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications and compounds for US Investigational New Drug (IND) applications, Canadian and/or EU Clinical Trial Applications (CTAs), and other jurisdictions as applicable.
  • Serves as main contact with US Food and Drug Administration (FDA) and Health Canada, and liaises with other country Regulatory Agencies when needed, directly or in coordination with local country representation; leads agency meeting preparation and attends key agency meetings to ensure full discussion of issues and opportunities and to track critical outcomes and commitments.
  • Provides guidance to all appropriate departments to assure compliance with applicable regulations; keeps up-to-date about current regulations and guidance's and interprets and notifies appropriate personnel as appropriate.
  • Develops, reviews and maintains Regulatory and other company-wide and departmental policies and SOPs.
  • Determines and supports emerging department and local business needs in relation to Global Regulatory Affairs.
  • Provides interpretation of regulatory agencies' feedback, policies and guidelines to internal colleagues and serves as the liaison between the company and regulatory agencies.
  • Develops regulatory strategic plans in conjunction with project teams and assists in the design of nonclinical and clinical programs required for regulatory approval.
  • Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained in a timely manner.
  • Responsible for filing of IND, CTA, and other required regulatory submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other functional areas and external vendors as necessary, in the preparation, review, and completion of documents for regulatory submissions.
  • Effectively plans, organizes and conducts, in close collaboration with leads from other functional areas, formal meetings with regulatory agencies. Interacts 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. Assure compliance with project team timelines and milestones.
  • Provides organizational support and is prepared to manage regulatory personnel as the company grows its product development pipeline.
  • Identifies gaps in product development plans that may pose regulatory issues.
  • Participates in regulatory due diligence activities.

QUALIFICATIONS:

  • A Bachelor's, master's or PhD in a scientific, medical or regulatory discipline and a minimum of 8 years progressively responsible Regulatory Affairsexperience (with at least 5 years of experience in a regulatory leadership role) in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
  • Demonstrated, hands-on experience leading, managing and preparing regulatory submissions.
  • Demonstrated track record of successful regulatory approvals and strategies in major business regions.
  • Prior regulatory agency liaison experience with a major regulatory agency.
  • Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
  • Ability to develop global risk assessment scenarios prior to functional and team reviews.
  • Ability to influence without direct authority.
  • Balance strategic thinking and strong analytical skills with the ability to execute.
  • Detail oriented with excellent written and verbal communication and presentation skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Special knowledge, skills and/or licenses or certificates preferred, such as Regulatory Affairs Certification (RAC).
  • Proficiency with Microsoft Excel, PowerPoint, Project and Word programs.
  • Experience in rare disease indications and/or orphan drug development desirable.
  • Experience interacting with FDA division of neurology would be an asset
  • Willingness and ability to travel domestically and internationally is required.

Salary

$225K - $275K