Associate 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 Associate 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 provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D.

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

Responsibilities

• Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed


• Develop submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, and develop risk mitigation strategies


• Coordinate submission development, developing and authoring content as applicable. Direct subject matter experts in content development and authoring. Ensure documents take a data-driven regulatory approach


• Provide ongoing guidance to project teams


• Triage and coordinate responses to questions from regulatory authorities


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


• Share best practices across the broader Regulatory Affairs organization


• Manage regulatory policy and intelligence activities, including commenting on guidance and monitoring the competitive and policy landscape for changes with potential impact

Qualifications

• Degree in life sciences; advanced degree preferred


• At least 6-10 years' experience in the biopharma industry, preferably in neurology


• Experience as primary regulatory author for IND and CTA documents


• Strong knowledge of FDA, EMA, and ICH regulatory guidelines and eCTD structure


• 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; able to be a situational leader when required


• Highly skilled at 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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