Regulatory Affairs Manager

Regulatory Affairs Manager (m/w/d)

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

We are looking for a Regulatory Affairs Manager to support the Technical Director in the development and implementation of the strategic regulatory plan. The role will have primary responsibility for European wide registrations and license maintenance to ensure timely approvals in alignment with Grifols European business objectives. If (or when) qualified, the position will also serve as the Information Officer according to § 74 a German Drug Act (AMG), who is responsible for ensuring compliance with the prohibition concerning deception as described in § 8 sub-section 1 No. 2 (AMG) and ensuring that the labelling, package leaflets, professional information and advertisements correspond with the content of the marketing authorization.

What your responsibilities will be

You will have the opportunity to:

• Coordinate European Marketing Authorization maintenance and regulatory life cycle management of assigned products.
• Prepare regulatory documentation in collaboration with colleagues at Grifols Headquarters and/or manufacturing sites in close cooperation with RA Biopharma.
• Coordinate submission of these dossiers to the appropriate regulatory authorities (e.g. Paul-Ehrlich-Institut/PEI or Bundesinstitut für Arzneimittel und Medizinprodukte/BfArM in Germany or EMA) and distribution to external RA partners in the concerned countries as needed.
• Coordinate compilation of product information according to national and European laws and regulations for the products assigned.
• Coordinate and contribute to label development and release of packaging materials.
• Serve as the product primary contact with PEI/BfArM or other competent authorities to ensure the licensing and maintenance of product(s) marketing authorization(s).
• Coordinate the timely preparation and submission of national documentation for (purely) nationally marketing authorizations, including responses to questions from regulatory authorities.
• Collaborate with Global Regulatory Affairs, Pharmacovigilance, local Quality and Medical Affairs in the preparation and submission of required documentation.
• Support maintaining regulatory intelligence database regarding national and EU regulatory requirements through review of publications, attendance at seminars and direct communication with outside regulatory personnel, including regulatory authorities.
• Participate in review of promotional materials (GRP) and ensures compliance with European regulations and guidelines.
• Support conduct of authority meetings (e.g. scientific advice).
• Attend seminars and industry trade association meetings, and where appropriate, serves as company representative on committees and task forces.

Information Officer:

• Verify that the scientific information about the medicinal product complies with the current status of the marketing authorization.
• Control and approve the mock-ups of new packaging material (labeling and package insert) to ensure that it is in agreement with the authorized product information.
• Release the new/updated SmPC (Fachinformation) for publication and distribution and block the old superseded SmPC.
• Control and approve the promotional material with regard to the prohibition concerning deception (§ 8 sub-section 1 No. 2 and § 3 German Drug Advertisement Act (HWG)).
• Responsible for compilation and revision of SOPs describing the release procedures.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master’s Degree is also required.
• You have at least 4 years of relevant experience in European pharmaceutical Regulatory Affairs, ideally in biological products/plasma derived products.
• You have good knowledge of German national and EU regulatory requirements and laws.
• You have experience with eCTD and respective tools desirable.
• You have a qualification as Information Officer according to §74a AMG (desirable).
• You possess good computer skills (MS Office and RA related software).
• You possess good communication and organization skills.
• You are a structured, diligent, self-motivated and results-oriented person, with high attention to detail.
• You are a team player, able to collaborate with cross-functional teams to achieve the objectives.
• You speak fluent German and English.

What we offer

It’s a brilliant opportunity for someone with the right talents.

Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.

Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

Grifols is an equal opportunity employer.

Benefits package

Contract of Employment: Permanent position

Flexibility for U Program: Hybrid work model