Huidige banen gerelateerd aan Regulatory Affairs Liaison Oncology - Oss, Noord-Brabant - MSD

Job Description

Do you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer?

We have a new, exciting opportunity for a Regulatory Affairs Liaison Oncology (Senior scientist) to be based in Oss (NL), Brussels (BE), or London (UK).

Purpose of the position

In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non-EU SEE countries under the supervision of the (Senior) Principal Scientist of Regulatory Affairs. You will be responsible for implementing strategies for products in development with their guidance and independently developing and executing strategies for registered products. Additionally, you will play a crucial role in managing submissions and interactions with the EU regulatory agencies. It will be your responsibility to directly liaise with HQ US-based cross-functional teams, effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects. You will also coordinate or oversee the preparation of regulatory documentation in a timely manner, aligning with corporate objectives. Furthermore, as an integral part of the team, you will serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.

The department

Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Cancer is one of the most significant global health challenges today, representing one of the world's most urgent unmet medical needs. Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. Our current portfolio in oncology is creating countless opportunities and challenges for the oncology team. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day

Primary activities

• Under supervision from the (Senior) Principal Scientist, coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
• Work with cross-functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
• Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
• Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
• Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
• Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
• Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
• Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.

Your profile

• Master's degree in pharmacy, chemistry, or equivalent, preferably in a science-related field. Minimum of 2 years of experience in the pharmaceutical industry is preferred.
• Strong organizational and planning skills, with the ability to manage multiple projects and adapt to changing priorities.
• Knowledge of EU regulations, guidelines, and regulatory processes for product life cycle maintenance.
• Ability to work in a cross-functional and international environment.
• Fluent written and spoken English is required, along with strong interpersonal, oral, and written communication skills.
• Willingness to travel up to 5% for job-related activities.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:09/09/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R305994