Specialist Regulatory Affairs
1 maand geleden
Job Description
Did you always want to work in a company where your work can have a real impact? Do you enjoy working in an international environment with lots of room for personal development?
We have an exciting opportunity at the Boxmeer facility for a:
Specialist Regulatory Affairs (Poultry)
Welcome in our team
Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally. GRA Biologicals is a part of this department and responsible for the biological product portfolio.
Major activities of Global Regulatory Affairs Biologicals are:
- Providing state of the art dossiers, variation and renewal packages for licensing of new Biological products and maintenance of the existing biological product portfolio.
- Providing veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant departments.
- Developing regulatory strategies for new and existing biological products.
- Maintaining the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company.
- Developing and maintaining contacts with regulatory authorities.
- Participating in regulatory expert groups within the veterinary pharmaceutical industry association(s) to play a role in the development of future veterinary legislation and guidelines.
The Specialist – Licensing will be a member of a RA species team within Global RA Biologicals. GRA Biologicals has a RA poultry, swine/aqua and companion animal/ruminants species team. The RA species teams have end-to-end responsibility for all regulatory aspects of its species product portfolio (mainly vaccines) including new product registration as well as regulatory maintenance/life cycle management of registered products. The RA species teams are also responsible for the management of project timelines associated with regulatory activities including proper and timely involvement of other GRA teams/functions needed for these activities. The main area of responsibility of Licensing managers is all licensing aspects of regulatory submissions of the biological's product portfolio, including new product registration and regulatory maintenance/life cycle management of approved products. Outside of the US, the licensing manager functions as a key regulatory interface for Regulatory Agencies, Country Operations RA, Regional GRA coordinators, our Company's Manufacturing Division, and other relevant departments.
The Specialist supports the licensing activities related to new registrations and life cycle management to ensure efficient new licensing, product portfolio maintenance/improvement and regulatory compliance.
You will become part of the RA poultry species team. The focus of your activities will be supporting new submissions and regulatory maintenance of our poultry portfolio in countries outside the EU.
Responsibilities
- Acts as first point of contact within GRA for Local RA colleagues (CORA's) and as intermediate between RA product managers and CORA's.
- Maintains good working relations with the contacts within GRA (Product Managers, Operations, Pharmacovigilance), within our organization (CORA's, MMD) – local and international and outside our organization (3rd party CORA's, Dutch Ministry).
- Sends out dossiers/variation packages to the CORA's and/or competent authorities and ensure timely follow up.
- Arranges required other (legalized) documents, information, and all other items (e.g., samples, test materials) necessary for obtaining and maintaining marketing authorizations.
- Ensure timely availability of the requested documents and materials, in line with the licensing strategy.
- Manages according to schedule all actions for obtaining new or amended translations for centrally authorized products via CORAs including communication with CORAs and EMA on these activities.
- Prepares and manages timely submission of high-quality answers to questions from regulatory authorities during standard licensing procedures; Takes care of licensing questions.
- Communicates new, amended and renewed marketing authorizations including commitments to all stakeholders, checks these data involving, when applicable, subject matter experts (e.g., RA product managers), and enter these data in(to) applicable GRA information systems.
- Supports fulfillment of any regulatory commitment given during a registration procedure.
- Conducts, if applicable, standard licensing procedures with the support of team lead or other experienced licensing staff.
- Prepares overviews of changes in registration requirements of countries and with support to identify trends. Communicates changes/trends to relevant GRA teams and other internal stakeholders.
- Participates (with support) in (small) multi-disciplinary project teams providing licensing input for new product registrations and product maintenance.
- Participates (with support) in the design of optimal submission strategies for licensing procedures.
- Participates (with support) in general GRA projects related to document management system or regulatory database/platforms.
Animal Health Division
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry's most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
Your profile
- HBO Bachelor or equivalent in preferably Veterinary, (Bio) Chemistry, Biology, or Bio-Medical area. If no Higher Professional education, then proven skills and experience to work at such level.
- At least 1 to 3 years of experience in (veterinary) regulatory affairs, preferably in the field of (veterinary) biologicals.
- Good oral and written command of the English language. Good writing skills.
- Accurate, eye for detail, efficient, pragmatic, flexible, service and compliance minded, able to work under (time) pressure and well-developed cultural awareness.
- Excellent communication skills with ability to explain information and persuades others in accepting straightforward situations.
- Good team player skills.
- Ability to identify (licensing) issues in a range of straight-forward situations, analyze and assess them using standard procedures and propose possible solutions.
- Ability to act pro-actively based on planning information and licensing strategy.
- Knowledge and understanding of country-specific licensing requirements and of general aspects of product development, production and quality control. Ability to apply this for standard licensing issues.
- Ability to gain developed understanding of current internal processes and to contribute to improvement of standard processes.
- With limited support, ability to train colleagues on the job.
- Full proficiency with information systems.
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
- Competitive salary
- 35,5 days of leave
- Attractive collective health care insurance package with considerable reduction rates
- Solid Pension Plan
- Bonus plan subject to the company annual results
- Flexible working arrangements
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
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.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/31/2024*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.
Job Posting End Date:05/31/2024
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:R288011
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