Senior Director, Regulatory Affairs
Location
Waltham, MA | United States
Job description
Job Description
The Opportunity 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 Primary 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
- Effectively represent the Regulatory Affairs function to senior leadership at governance meetings
Qualifications Basic Requirements: - Degree in life sciences; advanced degree preferred
- At least 12 years' experience in the biopharma industry in a Regulatory Lead role
Preferred Requirements: - Proven ability to represent Regulatory on project teams and at Health Authority meetings
- 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
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About Us Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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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