Senior Director, Regulatory Affairs
Our client is a biotherapeutics company. They have asked us to assist them in a search for a Senior Director, Regulatory Affairs.
Major tasks and responsibilities include:
- Provides scientific and regulatory vision, leadership, and oversight for an assigned therapeutic area.
- Leads and coaches associated direct reports (as applicable) at the company’s global facilities.
- Supports the establishment and maintenance of high-quality working relationships with global regulatory agencies.
- Articulates the science and regulatory perspective to stakeholders.
- Ensures that all functional project deliverables for assigned portfolio are met.
- Participates in Health Authority meetings as required.
- Enables growth and professional development of team members and ensures team members have been trained on their role.
We seek candidates with the following qualifications:
- Implements and maintains global regulatory processes and operations for GPS.
- If acting as a GRL, serves as the primary Regulatory Interface on the Product Strategy Team (PST), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA, advocates and drives the ‘one GRA’ perspective with team stakeholders.
- A Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related life science is required. An advanced degree in a related field or MBA is preferred.
- Must have at least 15 years of experience in the biotech or pharmaceutical industry with at least 10 years in Regulatory Affairs.
- Must have at least seven years of experience in leading and managing teams, setting clear direction, holding people accountable and fostering a collaborative team environment within a matrix workplace.
- Requires a thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region.
- Requires extensive experience interfacing with regulatory agencies.
- Strong ethics and integrity are required.
- Must be able to think strategically, take prudent risks, and develop innovative solutions to regulatory challenges.
- The proven ability to build and lead effective, well integrated, collaborative teams, that empowers members is required.
- Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters is required.
- Must be able to translate complex scientific/regulatory topics to stakeholders, regardless of level.
- Requires the ability to make rapid, informed decisions and can coach team members to emulate this behavior.
- Must be fluent in English (verbal and written).
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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