Sr Director, Regulatory Affairs (Strategy) at Alkermes, Inc. in Waltham, Massachusetts

Job Description:

We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy.

This role reports to the Vice President, Head of Regulatory Strategy.

Responsibilities

• Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams


• Develop and implement global regulatory strategies for pipeline drug development programs and marketed products


• Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact


• Lead the organization and preparation of clear and effective regulatory submissions that align with company strategies and Health Authority requirements


• Foster strong relationships with relevant regulatory agencies and key stakeholders while advocating for company positions


• Lead interactions with Health Authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization.


• Create a strong regulatory community and share best practices across the broader Regulatory Affairs organization


• Represent the Regulatory Affairs function to senior leadership at governance meetings


• Contribute to regulatory policy and intelligence activities, lead teams commenting on guidance

Qualifications

• Degree in life sciences; advanced degree preferred


• At least 10-15 years' experience in the biopharma industry in a Regulatory Lead role and proven ability to represent Regulatory on project teams and at Health Authority meetings


• Experience bringing drugs through End of Phase 2 and onto approval, leading relevant health authority interactions


• Demonstrated strategic thinking skills, sound judgement, and ability to integrate strategies into actionable plans


• Strong knowledge of global regulatory principles and practices across the drug development lifecycle, ideally with an emphasis on neurology drugs


• A thorough understanding of the drug development process and working knowledge of the essential activities for all key functional areas


• Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely


• Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals


• Capable of project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk


• Able to work independently on competing priorities in a fast-paced and dynamic environment; a creative thinker with good attention to detail

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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