Director Regulatory Affairs Jobs

Your New Company!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.

About The Role

The Director, Regulatory Affairs, is responsible to provide strategic and regulatory guidance related to global clinical drug development. Lead, manage and grow regulatory services offering.

What You'll Do Here

• Provide critical review of key Health Authority submissions such as pre-IND, IND, meeting requests, briefing documents and response documents;
• May participate in scientific meetings, conferences, and courses/workshops representing Altasciences;
• Evaluate, develop, plan and implement regulatory strategies for new drugs under development with the collaboration of multiple cross-functional teams;
• Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines;
• Maintain a positive, result orientated work environment, build partnerships with cross-functional teams/departments, maintain a positive team-based culture;
• Participate in departmental or interdepartmental quality improvement initiatives;
• Participate in the development of standard operating procedures (SOPs);
• Participate to sponsor’s audits and regulatory inspections ;
• Train and mentor other team members;
• Resolve issues in a timely manner;
• Communicate, consult and negotiate with health authorities;
• Lead, manage and prepare clinical trial submissions;
• Respond in a timely manner to health authority requests;
• Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines;
• Perform gap analysis for drug development programs and regulatory strategies;
• Interact with sponsors as a regulatory consultant to encourage engagement in regulatory activities aligned with clinical trials;
• Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide strategic and regulatory guidance related to global clinical drug development;
• Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
• Support business development for proposals and costing; support bid defense meetings;
• Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
• Provide regulatory input into client-provided proposals;
• Maintain and participate in the objectives of the department;
• Interpret laws and regulations (FDA, Health Canada, ICH, EMA, and MHRA);
• May assist in coordination of team workload;

What You’ll Need To Succeed

• Thorough understanding of clinical research, drug development process and applicable regulatory guidance;
• Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.
• Strong knowledge of drug development and regulatory policy;
• Undergraduate Degree, MSc/M.S., PhD in a relevant field;
• Ability to prioritize workload;
• Professional attitude and strong interpersonal skills;
• Leadership skills;
• Critical thinking skills and ability to acquire and apply knowledge quickly;
• Flexible attitude with respect to work assignments and new learning;
• Experience with leading clinical trial submissions in US, experience with other regulatory agencies a plus;
• Client-focused approach to work;
• 8+ years of regulatory experience in an industry setting;
• Excellent English verbal and written communication skills;
• French Language an asset;
• Ability to work well with a multi-disciplinary team of professionals;

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes

• Health/Dental/Vision Insurance Plans
• Employee Assistance & Telehealth Programs
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Telework when applicable
• 401(k)/RRSP with Employer Match

Altasciences’ Incentive Programs Include

• Employee Referral Bonus Program
• Annual Performance Reviews
• Training & Development Programs

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

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