Manager / Sr. Manager, Regulatory Affairs
San Diego, CA
Secura Bio is a pharmaceutical company with approved oncology therapeutics in the United States and in other global markets.
The Manager/Sr. Manager, Regulatory Affairs will be a key contributor to Secura Bio’s regulatory compliance programs, with the primary responsibilities of implementing and maintaining adequate systems for regulatory submissions to FDA and other regulatory agencies. Responsibilities will also include regulatory documents preparation and review, management of vendors and submission timelines, general documentation authorship and review. The position will report to the Vice President, Manufacturing, Regulatory & Quality.
Key Responsibilities Include:
- Coordinate internal efforts to prepare regulatory submission documents.
- Prepare and maintain a calendar of regulatory submissions for assigned products (Annual Reports, REMS Assessments, DSUR, PSUR and other Safety Reports, SUSARs, etc.).
- Become proficient with product related regulatory requirements in different environments, mainly USA (FDA) and Europe (EMA).
- Identify new regulatory requirements and updates applicable to assigned products, anticipating actions required to remain in full compliance in respective geographies.
- Actively coordinate regulatory submissions, interacting with vendors and partners as needed.
- Follow U.S. and European regulations for GMP, identifying changes and updates to be applied to the company’s systems and processes.
- Support, interact and communicate with partners to ensure activities are conducted successfully and according to timelines.
- Coordinate with internal and external partners to gather information and documents necessary for timely submission of periodic reports (e.g., annual report, safety reports, etc.).
- Provide input and review to labeling materials to ensure contents and format agree with approved licenses.
- Submit promotional materials for review by experts as needed, and ultimately prepare and manage submissions to FDA’s OPDP or other entities.
- Interact with partners and vendors to gather necessary pharmacovigilance information to maintain licenses up to date via appropriate submissions.
- Lead efforts and provide guidance to colleagues in the generation and revision of GMP documentation (e.g., procedures, specifications, etc.) based on regulatory approvals.
- Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
- Minimum five (5) years of relevant experience in pharmaceutical and/or biotech regulatory affairs disciplines.
- Minimum of three (3) years of functional leadership experience.
- Thorough knowledge of cGMP regulations and good documentation practices.
- Thorough understanding of Regulatory Affairs and CMC operations.
- Detail oriented with strong written and verbal communication skills.
- Proven ability to lead and manage projects and teams.
- Experience interacting with suppliers, regulators and senior staff.
- Strong organizational and analytical skills.
- Must have excellent customer service attitude.
- Ability to develop, recommend and implement procedures.
- Aptitude and motivation to learn and assume new responsibilities.
- Experience working in a start-up environment.
- Strong MS Office and presentation skills.
- Supervisory experience a plus.
- Experience with Electronic Documentation Management Systems (EDMS) is a plus
Secura Bio offers competitive compensation and generous benefits.
If you meet the requirements for this position, please email us at firstname.lastname@example.org.