Posted in Management 30+ days ago.
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Location: Lynnfield, Massachusetts
The Associate Director, Regulatory Affairs – Gene Therapy manages, and actively contributes to, the development, planning and execution of regulatory strategies for development, registration and, as required, post-authorization initiatives for gene therapy products.
The incumbent’s primary responsibilities include, but may not be limited to, representing the Regulatory Affairs function at program team meetings; providing regulatory direction and oversight for development strategies; ensuring alignment with department objectives and program/company goals; identifying and developing solutions to regulatory issues leading to resolution and appropriate internal and external communications; and maintaining compliance with Company’s procedures, policies, and global regulatory commitments.
The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.
The Associate Director, Regulatory Affairs – Gene Therapy ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
• Manages the development, preparation and implementation of regulatory strategies to obtain, maintain and extend gene therapy product development and registrations globally and 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 gene therapy-related regulatory documents for various submissions, including but not limited to, marketing and clinical trial applications and their maintenance, amendments, and variations as well as 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.
• Actively works with Project Management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across gene therapy indications for marketing authorizations (including Biologic License Applications (BLAs)) and Investigational New Drug applications (INDs).
• Serves as the main contact with US Food and Drug Administration (FDA) 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; remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
• Develops, reviews and maintains Regulatory and other company-wide and departmental policies and SOPs.
• Supports emerging department and local business needs as determined by regulatory department leadership.
Describe the following criteria, which are necessary to effectively perform the position:
Minimum level of education and years of relevant work experience.
• Bachelor’s degree in a relevant discipline and a minimum of 7 years progressively responsible Regulatory Affairs experience, at least 3 of which have been in a regulatory strategy role (ideally supporting gene therapy products), in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
• Demonstrated track record of success managing the development and execution of regulatory strategy and the associated regulatory activities in major business regions.
• Prior regulatory agency liaison experience with major regulatory agencies.
• Demonstrated ability to maintain his/her knowledge of current regulatory requirements as well as the emerging regulatory landscape for gene therapy products.
• Ability to develop global risk assessment scenarios prior to functional and team review.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, 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 or skills and/or licenses or certificates preferred.
• Advanced degree (PharmD, PhD).
• Project management experience.
* Travel requirements
10 – 20 %
Office based position
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.