Associate Director Regulatory CMC Combination Products ...

Work Location:Boston, MassachusettsShift:Department:HC-RD-RCH Digital Health & DevicesRecruiter:Rena Ann PetersonThis information is for internals only. Please do not share outside of the organization.Your Role:The Associate Director Regulatory Affairs Medical Devices is responsible for the regulatory strategy of our drug-device combination products for our medicinal products.Develop global regulatory strategies for submissions and approvals of drug-device combination products (including co-packaged medical devices) for marketing authorization applications including LCM activities within our medical-device and drug/device combination products portfolio.Implement drug-device combination products in clinical-trial programs aimed at medicinal products.Implement regulatory strategy for drug/device combination products, in conjunction with technical, development, quality, commercial, IP and business development teams by supporting projects and work streams according to agreed deliverables, timelines, and budget.Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development.Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy.Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities.Who You AreMinimum Qualifications:Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline).Over 8 years of experience in regulatory affairs of drug-device combination products and/or medical devices for worldwide submission.Proven expertise in building global regulatory strategy including building submissions-dossier for global submissions especially in the EU (MAA/Notified Body Opinion - NBOp, CTA) and US (IND, NDA/BLA (for combination products), 510K, PMA).Preferred Qualifications:Proven track record of effective collaboration with regulatory authorities in the form of scientific advice meetings and demonstrated ability to act as a credible, influential, respected spokesperson during such interactions.Prior experience working with CMC and connected drug/device combination products for medicinal products is desirable.Good understanding of the drug-device combination and medical-device regulatory framework in EU, US, and international countries such as ICH, EU-MDR, MDSAP, ISO-13485, cGMP for combination products, QMS and technical file for medical devices, eCTD and MCDG guidelines.Strong team player; able to work within a highly multidisciplinary environment. Effective communication with team members and stakeholders with diverse backgrounds.Fluency in English is mandatory.Possible location:Boston (US), OR Eysins (Switzerland) OR Darmstadt (Germany)The Pay Range for this position: $118,600 to 178,000Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.#J-18808-Ljbffr

Created: 2025-02-21