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Head Of Regulatory Affairs


This is a Contract position in Boston, MA posted May 15, 2022.

Simcere Pharmaceutical Group Limited(2096.HK) is rapidly transitioning to innovation and R&D-driven pharmaceutical company, with a mission of “providing today’s patients with medicines of the future.” Simcere focuses on three therapeutic areas: oncology, central nervous system diseases, and autoimmune diseases, with a diversified product portfolio and industry-leading capabilities.

Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world-leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to patience in China.

We have been continuously recognized as one of the “Top 10 Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China ”.

Simcere Pharmaceutical Group has the ambition to develop our presence further globally, focusing on the US and Europe by continuously expanding our early discovery sites, Business Development organization, and clinical development capabilities.

As an organization, we value Integrity, Strive for Excellence, Resilience, Proactivity, and Customer/patient First.

KEY RESPONSIBILITIES Provide Regulatory leadership for the Global Regulatory team across all programs, providing strategic direction for the advancement of the company pipelines, with emphasis on the global trial development and roadmap Formulate and oversee implementation of regulatory strategy and activities Lead, plan, and manage high-quality deliverables for all regions (with focus on the US and another related global market), consistent with the global regulatory strategy and Clinical Development Plans Develop and maintain relationships with external vendors and regulatory health authorities Contribute to the growth of the Regulatory Department, including the development of regulatory systems and processes to support the team Maintain and amplify knowledge of global regulatory requirements and relevant new intelligence with the wider Regulatory team as needed Build and mentor the Global Regulatory team to ensure high-quality output and to foster personal career growth for all team members Knowledge of CDE (Center for Drug Evaluation) regulation is a plus Essential Skill Sets Recognized scientific leadership and a strong background in regulatory science/regulatory affairs/relevant scientific field, supporting novel drug product submissions.

Prior NDA and/or BLA initial application development experience and (or) a proven track record of effective collaboration with the FDA and EMA, knowledge of FDA CN and post-marketing is a plus.

Able to understand and interpret complex scientific issues and data sets across multiple programs as it related to regulatory requirements and strategy.

Experience forming and leading a matrix research team to achieve research milestones and development goals.

Adapt and thrive in an interactive, dynamic, multi-culture team environment and business acumen.

Professional Qualifications Doctorate or Master’s degree (or equivalent) in the relevant scientific field.

At least 6-8 years of regulatory experience in the biopharmaceutical industry and a minimum of 1-3 years of management/leadership experience.

In-depth knowledge of drug development process and regulatory requirements.

Ability to lead, influence, and motivate fellow colleagues across levels.