- Location: Madrid (40km)
- Office-based position
- Permanent contract directly hired by the Company
- Senior position 5-7 years of experience in Regulatory Affairs across different geographical territories and experience with NCE and generics; if not both, preferably generics.
- Travels: Not required.
- Define strategies for regulatory submissions for obtaining and maintaining approvals for products in international markets including local market.
- Participate in the preparation and/or review of documents together with the technical departments: study protocols, clinical and preclinical study reports, technical regulatory documents, written summaries, overviews, SmPC, PI, labels, etc.
- Manage customization of dossiers for international markets, organize submission and registration of products according to the defined timelines, supervise the partners’ Regulatory Affairs teams for submission of regulatory documentation and contact with local Health Authorities.
- Perform regular follow-up progress on regulatory submissions.
- Coordinate internally the answers to the deficiency letters ensuring the timelines given by the Regulatory Agencies.
- Cooperate in the review of the License agreements, Quality Technical agreements, Pharmacovigilance agreements and Clinical Trial agreements signed with the partners.
- Provide local or regional training as appropriate to comply with international regulatory requirements.
- Maintain and update the list of international regulations and guidance documents for biotech products.
- Cooperate with the clinical team in the regulatory part to obtain the clinical trial approval as well as participate in supporting the clinical team in the Health Authorities meetings.
- Participate in regulatory agencies audits and coordinate responses to support the audit findings or other actions.
- Perform regulatory support in the launching of the product and liaise with Supply Chain and Marketing functions.
- Respond to health authority queries.
- Participate in Scientific Advice meetings with regulatory agencies.
- Education: Degree in Chemistry, Pharmacy or life sciences.
- Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
- Experience (years/area): Senior position 3-5 / junior position 1-3 years of experience in Regulatory Affairs across different geographical territories and experience with NCE and generics; if not both, preferably generics.
- Specific Knowledge: Knowledge of legislation related to DMF (Drug Master File) in CTD format. Knowledge of GMP Regulations.
- Travels: Not required.
- Personal skills: Ability to work across cultures, under pressure and with tight deadlines. Initiative, strong problem solving and negotiation skills.