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

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

What You’ll Need To Succeed

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

What We Offer

The pay range estimated for this position is $105,000-$130,000 annually. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

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

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

Altasciences' Incentive Programs Include

• Training & Development Programs
• Employee Referral Bonus

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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